FDA product code FFY: Adaptor, Bulbs, Miscellaneous, For Endoscope
FFY is the FDA product code for adaptor, bulbs, miscellaneous, for endoscope. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FFY, from 2 different applicants. The average 510(k) review took 202 days (median 202).
Classification
| Field | Value |
|---|---|
| Device name | Adaptor, Bulbs, Miscellaneous, For Endoscope |
| Device class | Class I |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FFY clearance
Top FFY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Columbia Medical & Surgical, Inc. | 1 | 1994-04-07 |
| Applied Urology, Inc. | 1 | 1990-04-25 |
Most recent FFY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932128 | Columbia Medical & Surgical, Inc. | CMI E-Z FLO BULB P.N. 701 | 1994-04-07 | 339 |
| K900781 | Applied Urology, Inc. | WORKING CHANNEL VALVE | 1990-04-25 | 64 |
Recalls for FFY devices
openFDA lists no recalls for product code FFY.
Frequently asked questions
What is FDA product code FFY?
FFY is the FDA product code for adaptor, bulbs, miscellaneous, for endoscope. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FFY?
Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FFY?
Across 2 cleared submissions the average was 202 days from receipt to decision (median 202).
Which companies have the most FFY clearances?
Columbia Medical & Surgical, Inc. (1); Applied Urology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FFY
- Run a recall and safety report across every FFY manufacturer
- Watch product code FFY 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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