FFSClass II
Image, Illumination, Fiberoptic, For Endoscope
21 CFR 876.1500 / Gastroenterology, Urology
FFS is the FDA product code for Image, Illumination, Fiberoptic, For Endoscope, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- FFS
- Device name
- Image, Illumination, Fiberoptic, For Endoscope
- 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
- 26
- Ingested recalls
- 2
Clearances, product code FFS
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 3 |
| 1985 | 1 |
| 1989 | 3 |
| 1993 | 1 |
| 1994 | 4 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 3 |
| 1999 | 1 |
| 2000 | 2 |
| 2002 | 1 |
| 2006 | 1 |
| 2007 | 3 |
Applicants with the most clearances
Product code FFS| Applicant | Clearances |
|---|---|
| Cogent Light Technologies, Inc. | 2 |
| Incredivision, Inc. | 2 |
| Karl Storz Endoscopy-America, Inc. | 2 |
| Smith & Nephew, Inc. | 2 |
| Accutech Medical Technologies, Inc. | 1 |
| Alm Surgical Equipment, Inc. | 1 |
| Cook Incorporated | 1 |
| Douglas Manufacturer Co. | 1 |
| Dutch Ophthalmic USA, Inc. | 1 |
| Endo Lase, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
