FDA Product Code
FDA Product Code MPA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 41 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253468 | Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A) | Nova Eye, Inc. | 2026-08-10 | Traditional | PDF ↗ |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); | Alcon Laboratories, Inc. | 2024-12-04 | Traditional | PDF ↗ |
| K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) | Peregrine Surgical, LLC | 2024-08-05 | Traditional | PDF ↗ |
| K221872 | ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System | Nova Eye Inc. (Business Name Nova Eye Medical) | 2023-03-30 | Abbreviated | PDF ↗ |
| K202670 | Nam illumination probe with chopper | Oculight , Ltd. | 2021-08-20 | Traditional | PDF ↗ |
| K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | Peregrine Surgical , Ltd. | 2015-09-11 | Traditional | PDF ↗ |
| K143123 | Synergetics PHOTON EX | Synergetics | 2015-02-24 | Traditional | PDF ↗ |
| K080067 | ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER | Iscience Interventional | 2008-07-18 | Traditional | PDF ↗ |
| K062895 | XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII | Dutch Ophthalmic Research Center International BV | 2006-10-13 | Special | PDF ↗ |
| K062259 | ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 | Iscience Surgical | 2006-08-15 | Traditional | PDF ↗ |
| K041108 | ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA | Iscience Surgical Corporation | 2004-06-22 | Traditional | PDF ↗ |
| K032598 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE | Synergetics, Inc. | 2003-11-24 | Traditional | PDF ↗ |
| K000252 | INSIGHT 4000 ENDOSCOPE | Insight Instruments Mfg., Inc. | 2000-10-17 | Traditional | PDF ↗ |
| K000416 | TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 | Retinalabs.Com | 2000-05-08 | Traditional | PDF ↗ |
| K980797 | PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR | Peregrine Surgical , Ltd. | 1998-05-19 | Traditional | PDF ↗ |
| K980530 | PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 | Peregrine Surgical , Ltd. | 1998-05-12 | Traditional | PDF ↗ |
| K980027 | PEREGRINE SHIELDED DIFFUSION PROBE | Peregrine Surgical , Ltd. | 1998-03-31 | Traditional | PDF ↗ |
| K980025 | PEREGRINE TAPERED DIFFUSION PROBE | Peregrine Surgical , Ltd. | 1998-03-31 | Traditional | PDF ↗ |
| K973229 | D.O.R.C. HEXON ILLUMINATION SYSTEM | Dutch Ophthalmic USA, Inc. | 1997-11-25 | Traditional | PDF ↗ |
| K973293 | SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR | Vaughan Weeks | 1997-11-18 | Traditional | PDF ↗ |
| K973290 | SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK | Vaughan Weeks | 1997-11-14 | Traditional | PDF ↗ |
| K973757 | D.O.R.C. SOLUX LIGHT SOURCE | Dutch Ophthalmic USA, Inc. | 1997-11-07 | Traditional | PDF ↗ |
| K971679 | I-SCOPE OPHTHALMIC ENDOSCOPE | Ophthalmic Technologies, Inc. | 1997-06-25 | Traditional | PDF ↗ |
| K970882 | ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.) | American Medical Devices, Inc. | 1997-06-24 | Traditional | PDF ↗ |
| K964005 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE | Synergetics, Inc. | 1997-06-09 | Traditional | PDF ↗ |
| K970875 | ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) | American Medical Devices, Inc. | 1997-05-20 | Traditional | PDF ↗ |
| K964405 | MBI ILLUMINATED RETINAL PICK | M.B. Industries, Inc. | 1997-05-13 | Traditional | PDF ↗ |
| K964553 | MBI CO-AXIAL ILLUMINATED RETINAL PICK | M.B. Industries, Inc. | 1997-05-13 | Traditional | PDF ↗ |
| K970878 | ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT | American Medical Devices, Inc. | 1997-05-06 | Traditional | PDF ↗ |
| K971338 | SYNTEC, INC. DISPOSABLE BARE END FIBER | Syntec, Inc. | 1997-05-06 | Traditional | PDF ↗ |
| K964555 | VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S) | Vitrotec, Inc. | 1997-03-31 | Traditional | PDF ↗ |
| K963417 | VITLITE (TR7700) | Escalon Trek Medical | 1996-12-20 | Traditional | PDF ↗ |
| K961036 | MBI FIBEROPTIC ENDO-ILLUMINATOR | M.B. Industries, Inc. | 1996-07-15 | Traditional | PDF ↗ |
| K960007 | STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR | Storz | 1996-03-26 | Traditional | PDF ↗ |
| K952585 | GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR | Gamp & Assoc. | 1996-01-05 | Traditional | PDF ↗ |
| K952581 | GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR | Gamp & Assoc. | 1996-01-05 | Traditional | PDF ↗ |
| K951627 | INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM | Infinitech, Inc. | 1995-10-19 | Traditional | PDF ↗ |
| K946136 | INFINITECH LIGHTED INFUSION CANNULA | Surgical Technologies, Inc. | 1995-10-02 | Traditional | PDF ↗ |
| K952580 | GAMP & ASSOCIATES DISPOSABLE BARE END FIBER | Gamp & Assoc. | 1995-09-01 | Traditional | PDF ↗ |
| K952584 | GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK | Gamp & Assoc. | 1995-09-01 | Traditional | PDF ↗ |
| K952586 | GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR | Gamp & Assoc. | 1995-09-01 | Traditional | PDF ↗ |
Product code MPA · Class II · Gastroenterology, Urology. Data: openFDA.