FDA product code FFN: Clamp, Non-Electrical
FFN is the FDA product code for clamp, non-electrical. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under FFN, from 4 different applicants. The average 510(k) review took 61 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Non-Electrical |
| Device class | Class I |
| Regulation | 21 CFR 876.4730 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FFN clearance
Top FFN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zinnanti Surgical Instruments, Inc. | 2 | 1989-05-09 |
| Baxter Healthcare Corp | 1 | 1993-09-28 |
| Fred Sammons, Inc. | 1 | 1978-01-26 |
| Quinton, Inc. | 1 | 1977-10-25 |
Most recent FFN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932408 | Baxter Healthcare Corp | AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS | 1993-09-28 | 133 |
| K892542 | Zinnanti Surgical Instruments, Inc. | RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU | 1989-05-09 | 28 |
| K892550 | Zinnanti Surgical Instruments, Inc. | BEST COLON CLAMP | 1989-05-09 | 28 |
| K772405 | Fred Sammons, Inc. | TUBING CLAMP | 1978-01-26 | 30 |
| K771421 | Quinton, Inc. | CATHETEO CLAMP | 1977-10-25 | 85 |
Recalls for FFN devices
openFDA lists no recalls for product code FFN.
Frequently asked questions
What is FDA product code FFN?
FFN is the FDA product code for clamp, non-electrical. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is FFN?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FFN?
Across 5 cleared submissions the average was 61 days from receipt to decision (median 30).
Which companies have the most FFN clearances?
Zinnanti Surgical Instruments, Inc. (2); Baxter Healthcare Corp (1); Fred Sammons, Inc. (1); Quinton, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FFN
- Run a recall and safety report across every FFN manufacturer
- Watch product code FFN 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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