FDA product code FFS: Image, Illumination, Fiberoptic, For Endoscope
FFS is the FDA product code for image, illumination, fiberoptic, for endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 26 510(k) submissions under FFS, from 22 different applicants. The average 510(k) review took 82 days (median 67). FDA has posted 2 recalls for FFS devices.
Classification
| Field | Value |
|---|---|
| Device name | Image, Illumination, Fiberoptic, For Endoscope |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FFS clearance
Top FFS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cogent Light Technologies, Inc. | 2 | 2000-07-17 |
| Smith & Nephew, Inc. | 2 | 2000-01-20 |
| KARL STORZ Endoscopy-America, Inc. | 2 | 1996-09-04 |
| Incredivision, Inc. | 2 | 1994-04-08 |
| Cook Urological, Inc. | 1 | 2007-11-20 |
17 more applicants have FFS clearances. See the full list in Caduvo.
Most recent FFS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072521 | Cook Urological, Inc. | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | 2007-11-20 | 74 |
| K061622 | Photonic Optische Gerate Gesmbh & Cokg | PS SERIES | 2007-03-05 | 266 |
| K063309 | Truphatek International, Ltd. | TRU-CABLE | 2007-01-12 | 71 |
| K061025 | Accutech Medical Technologies, Inc. | ACCUTECH ENDOLITE PROBE | 2006-05-31 | 48 |
| K023633 | Sovis Optique | SOVIS OPTIQUE'S ENDOSCOPIC CABLE | 2002-12-31 | 63 |
Recalls for FFS devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-05-03.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code FFS?
FFS is the FDA product code for image, illumination, fiberoptic, for endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FFS?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FFS?
Across 26 cleared submissions the average was 82 days from receipt to decision (median 67).
Which companies have the most FFS clearances?
Cogent Light Technologies, Inc. (2); Smith & Nephew, Inc. (2); KARL STORZ Endoscopy-America, Inc. (2); Incredivision, Inc. (2); Cook Urological, Inc. (1).
Have FFS devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2017-05-03.
Next steps
- Run an FDA pathway report with predicate devices for product code FFS
- Run a recall and safety report across every FFS manufacturer
- Watch product code FFS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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