FDA Product Code
FDA Product Code FCX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 25 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262152 | VS-370CF, VS-370CT | VISION MEDICAL Co., Ltd. | 2026-07-24 | Traditional | PDF ↗ |
| K240847 | MedicCO2LON (MedicCO2LON) | Ide Vision, Ltd. | 2024-10-30 | Traditional | PDF ↗ |
| K230474 | EVA5 Insufflator | Palliare , Ltd. | 2023-03-24 | Special | PDF ↗ |
| K202922 | END 200 Endoscopic Tubeset | Palliare , Ltd. | 2021-07-08 | Traditional | PDF ↗ |
| K201096 | CO2mbiLED | Karl Storz Endoscopy America, Inc. | 2020-06-23 | Traditional | PDF ↗ |
| K190985 | BAROnova Insufflation System, BAROnova Accessory Kit | Baronova, Inc. | 2019-05-14 | Traditional | PDF ↗ |
| K180711 | FUJIFILM Endoscopic CO2 Regulator GW-100 | Fujifilm Corporation | 2018-05-25 | Special | PDF ↗ |
| K162332 | Nexcore GI Insufflator | Nexcore Technology, LLC | 2016-09-29 | Traditional | PDF ↗ |
| K133976 | FUJIFILM ENDOSCOPIC CO2 REGULATOR | Fujifilm Medical System U.S.A., Inc. | 2014-09-09 | Traditional | PDF ↗ |
| K132192 | BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR | Bracco Diagnostic, Inc. | 2014-02-14 | Traditional | PDF ↗ |
| K123047 | BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET | Bracco Diagnostic, Inc. | 2013-08-06 | Traditional | PDF ↗ |
| K113310 | ENDOGATER AVANTAGE CO2 INSUFFLATOR | Byrne Medical, Inc. | 2012-06-20 | Traditional | PDF ↗ |
| K111648 | BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR | Bracco Diagnostic, Inc. | 2011-11-03 | Special | PDF ↗ |
| K090879 | INSUFLOW CO2IONSHIELD | Lexion Medical, LLC | 2009-07-23 | Traditional | PDF ↗ |
| K063786 | ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 | Olympus Medical Systems Corporation | 2007-03-05 | Traditional | PDF ↗ |
| K053008 | E-Z-EM ENDOSCOPIC CO2 REGULATOR | E-Z-Em, Inc. | 2005-12-27 | Abbreviated | PDF ↗ |
| K030854 | PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 | E-Z-Em, Inc. | 2003-04-16 | Special | PDF ↗ |
| K013219 | PROTOCO2L INSUFFLATOR MODEL 6400 | E-Z-Em, Inc. | 2002-02-19 | Abbreviated | PDF ↗ |
| K945970 | INSUFFLATOR FILTER TUBING SET | Xylog Corp. | 1994-12-15 | Traditional | PDF ↗ |
| K930581 | E-Z-FLATE | E-Z-Em, Inc. | 1994-07-01 | Traditional | PDF ↗ |
| K935059 | INSUFFLATION TUBING SET, PHX500-082 | Phx Technologies Corp. | 1993-12-22 | Traditional | PDF ↗ |
| K930508 | HIFLO FILTERED INSUFFLATION TUBING | W. J. Medical Instruments, Inc. | 1993-06-25 | Traditional | PDF ↗ |
| K910716 | MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE | Richard Wolf Medical Instruments Corp. | 1991-04-16 | Traditional | PDF ↗ |
| K881004 | OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR | Keymed, Inc. | 1988-05-12 | Traditional | PDF ↗ |
| K844689 | ENDOSCOPIC MANUAL AIR INSUFFLATOR | Jayco Pharmaceuticals | 1985-01-02 | Traditional | PDF ↗ |
Product code FCX · Class II · Gastroenterology, Urology. Data: openFDA.