MPAClass II
Endoilluminator
21 CFR 876.1500 / Gastroenterology, Urology
MPA is the FDA product code for Endoilluminator, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 41 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- MPA
- Device name
- Endoilluminator
- Regulation
- 21 CFR 876.1500
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 41
- Ingested recalls
- 1
Clearances, product code MPA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1995 | 5 |
| 1996 | 5 |
| 1997 | 13 |
| 1998 | 4 |
| 2000 | 2 |
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 2 |
| 2008 | 1 |
| 2015 | 2 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code MPA| Applicant | Clearances |
|---|---|
| Peregrine Surgical, LLC. | 6 |
| Gamp & Assoc. | 5 |
| American Medical Devices, Inc. | 3 |
| M.B. Industries, Inc. | 3 |
| Synergetics Inc | 3 |
| Dutch Ophthalmic USA, Inc. | 2 |
| Iscience Surgical Corporation | 2 |
| Vaughan Weeks | 2 |
| Alcon Laboratories | 1 |
| Dutch Ophthalmic Research Center International BV | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Alcon Laboratories
- Bausch & Lomb Incorporated
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Fci France Chirurgie Instrumentation
- Fci SAS
- Fci Sud
- HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de C.V.
- Iridex Corporation
- Isomedix Operations Inc
- Katalyst Surgical, LLC
- Midwest Sterilization Corp.
- Nova Eye Inc.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
