FDA Product Code
FDA Product Code FCM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5130
510(k) Clearances — 60 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | C.R. Bard, Inc. | 2026-05-29 | Traditional | PDF ↗ |
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C | Convatec Limited | 2025-06-06 | Special | PDF ↗ |
| K223821 | Self-Cath Closed System | Coloplast | 2023-08-02 | Traditional | PDF ↗ |
| K082831 | AMSELF CLOSED CATHETERIZATION SYSTEM | Amsino International, Inc. | 2008-10-23 | Special | PDF ↗ |
| K070939 | SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM | Coloplast Manufacturing Us, LLC | 2007-06-01 | Special | PDF ↗ |
| K070048 | GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT | Marian Medical, Inc. | 2007-03-15 | Traditional | PDF ↗ |
| K030664 | AMSURE FOLEY INSERTION TRAY | Amsino International, Inc. | 2003-05-23 | Traditional | PDF ↗ |
| K030712 | AMSURE URETHRAL CATHETERIZATION TRAY | Amsino International, Inc. | 2003-05-23 | Traditional | PDF ↗ |
| K011055 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS | Go Medical Industries Pty. , Ltd. | 2001-06-06 | Traditional | PDF ↗ |
| K010420 | RUSCH MMG/O'NEIL CATHETER | Rusch, Inc. | 2001-05-09 | Traditional | PDF ↗ |
| K003873 | MENTOR SELF-CATH CLOSED SYSTEM | Mentor Corp. | 2001-03-29 | Traditional | PDF ↗ |
| K002803 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT | Go Medical Industries Pty. , Ltd. | 2000-12-27 | Traditional | PDF ↗ |
| K983010 | SELF CATH SET/SAFETY CATH | Rusch Intl. | 1999-02-12 | Traditional | PDF ↗ |
| K963993 | RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET | Rusch, Inc. | 1996-12-17 | Traditional | PDF ↗ |
| K962254 | NHMC URETHRAL CATHETERIZATION TRAY | National Healthcare Mfg. Corp. | 1996-07-29 | Traditional | PDF ↗ |
| K962073 | URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY | Continental Medical Laboratories, Inc. | 1996-06-21 | Traditional | PDF ↗ |
| K961442 | UNIVERSAL DRAINAGE TRAY | Customed, Inc. | 1996-05-09 | Traditional | PDF ↗ |
| K960215 | CPR URETHRAL CATHETER TRAY | Custom Pack Reliability | 1996-04-01 | Traditional | PDF ↗ |
| K960214 | CPR FOLEY CAHTETER KIT | Custom Pack Reliability | 1996-04-01 | Traditional | PDF ↗ |
| K960566 | NHMC FOLEY CATHETERIZATION TRAY | National Healthcare Mfg. Corp. | 1996-02-29 | Traditional | PDF ↗ |
| K951479 | CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1995-06-15 | Traditional | PDF ↗ |
| K950390 | URETHRAL CATHETERIZATION TRAY | Medcare Custom Packaging, Inc. | 1995-05-30 | Traditional | PDF ↗ |
| K951178 | UROLOGICAL CATHETER & ACCESSORIES | Deroyal Industries, Inc. | 1995-04-21 | Traditional | PDF ↗ |
| K950344 | HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER | Acacia Laboratories, Inc. | 1995-03-24 | Traditional | PDF ↗ |
| K950109 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER | Cypress Medical Products, Ltd. | 1995-02-27 | Traditional | PDF ↗ |
| K950092 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY | Cypress Medical Products, Ltd. | 1995-02-27 | Traditional | PDF ↗ |
| K942177 | FOLEY CATHETERIZATION TRAY | Customed, Inc. | 1994-09-08 | Traditional | PDF ↗ |
| K923538 | MON-A-THERM FOLEY KIT | Mallinckrodt Medical | 1993-05-27 | Traditional | PDF ↗ |
| K910653 | TOUCHLESS II INTERMITTENT CATHETER | C.R. Bard, Inc. | 1991-05-06 | Traditional | PDF ↗ |
| K910022 | MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT | Medical Marketing Group | 1991-04-02 | Traditional | PDF ↗ |
| K904158 | ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY | Welcon, Inc. | 1990-11-29 | Traditional | PDF ↗ |
| K903340 | STERILE URETHRAL CATHETER PROCEDURE KITS | Superior Healthcare Group, Inc. | 1990-10-04 | Traditional | PDF ↗ |
| K902508 | LAKE MALE EXTERNAL CATHETERIZATION KIT | Lake Medical Products, Inc. | 1990-08-23 | Traditional | PDF ↗ |
| K901183 | URETHRAL CATHETER TRAY (PVC) | Orion Life Systems, Inc. | 1990-07-20 | Traditional | PDF ↗ |
| K901185 | FOLEY CATHETER INSERTION TRAY (10CC) | Orion Life Systems, Inc. | 1990-07-20 | Traditional | PDF ↗ |
| K901184 | URETHRAL CATHETER TRAY (LATEX) | Orion Life Systems, Inc. | 1990-07-20 | Traditional | PDF ↗ |
| K901180 | FOLEY CATHETER INSERTION TRAY (30CC) | Orion Life Systems, Inc. | 1990-07-20 | Traditional | PDF ↗ |
| K901181 | CATHETER CARE TRAY | Orion Life Systems, Inc. | 1990-07-20 | Traditional | PDF ↗ |
| K896212 | URETHRAL CATHETERIZATION TRAYS | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-01-24 | Traditional | PDF ↗ |
| K790254 | FOLEY CATHETERIZATION TRAY | Snyder Laboratories, Inc. | 1979-04-10 | Traditional | PDF ↗ |
| K790271 | TRAY AND BAG, CATHETERIZATION | Snyder Laboratories, Inc. | 1979-03-06 | Traditional | PDF ↗ |
| K790272 | TRAY, URETHRAL CATHETERIZATION | Snyder Laboratories, Inc. | 1979-03-06 | Traditional | PDF ↗ |
| K780879 | URETHRO CATHETERIZATION TRAY | Abco Dealers, Inc. | 1978-07-31 | Traditional | PDF ↗ |
| K780735 | URINARY CATHETER CARE SET | Shield Laboratories, Inc. | 1978-06-13 | Traditional | PDF ↗ |
| K772277 | BLADDER RETENTION-CATHETHERIZATIONTRAY | Latex Ind., Inc. | 1978-03-02 | Traditional | PDF ↗ |
| K772341 | BLADDER KIT - 734000 | Latex Ind., Inc. | 1978-02-24 | Traditional | PDF ↗ |
| K780268 | BLADDER CATH KIT W/OUT CATHETER | Latex Ind., Inc. | 1978-02-24 | Traditional | PDF ↗ |
| K772342 | ROBINSON KIT - 750014 & 750016 | Latex Ind., Inc. | 1978-02-24 | Traditional | PDF ↗ |
| K772340 | CATHETERIZATION KIT 732016-732018 | Latex Ind., Inc. | 1978-02-24 | Traditional | PDF ↗ |
| K780123 | CATHETERIZATION PROCEDURE TRAY | Walpak Co. | 1978-02-21 | Traditional | PDF ↗ |
| K780124 | CATHETERIZATION PROCED. TRAY, URETHRAL | Walpak Co. | 1978-02-21 | Traditional | PDF ↗ |
| K771651 | AKRO-SIL FOLEY KIT 5CC | Latex Ind., Inc. | 1977-09-20 | Traditional | PDF ↗ |
| K771652 | CATH-CARE TRAY | Latex Ind., Inc. | 1977-09-20 | Traditional | PDF ↗ |
| K771650 | AKRO-SIL FOLEY KIT 30CC | Latex Ind., Inc. | 1977-09-20 | Traditional | PDF ↗ |
| K771104 | URETHRAL TRAY W/OUT CAHTETER, 7650 | Concord Laboratories, Inc. | 1977-06-24 | Traditional | PDF ↗ |
| K771103 | URETHRAL TRAY W/CATHETER, 7750 | Concord Laboratories, Inc. | 1977-06-24 | Traditional | PDF ↗ |
| K770496 | UNIVERSAL TRAY | Concord Laboratories, Inc. | 1977-03-21 | Traditional | PDF ↗ |
| K760048 | TRAY, URETHRAL CATHETERIZATION | M-C Ind., Inc. | 1977-03-01 | Traditional | PDF ↗ |
| K760127 | TRAY, CATHETERIZATION W/O CATHETER | Concord Laboratories, Inc. | 1976-10-07 | Traditional | PDF ↗ |
| K760128 | TRAY, CATHETERIZATION W/ CATHETER | Concord Laboratories, Inc. | 1976-10-07 | Traditional | PDF ↗ |
Product code FCM · Class II · Gastroenterology, Urology. Data: openFDA.