FDA product code GEN: Forceps, General & Plastic Surgery
GEN is the FDA product code for forceps, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 104 510(k) submissions under GEN, from 57 different applicants. The average 510(k) review took 35 days (median 25). FDA has posted 10 recalls for GEN devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Forceps, General & Plastic Surgery |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GEN clearance
Top GEN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Conphar, Inc. | 14 | 1982-05-28 |
| The Huxley Instrument Corp. | 8 | 1985-07-29 |
| Artiberia | 6 | 1985-07-01 |
| Mill-Rose Laboratory | 6 | 1982-04-26 |
| Edward Weck, Inc. | 5 | 1979-11-30 |
52 more applicants have GEN clearances. See the full list in Caduvo.
Most recent GEN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K031828 | Focus Medical, LLC | NATURALASE LP ND:YAG LASER | 2003-07-17 | 34 |
| K953962 | Biopsys Medical, Inc. | FORCEPS | 1995-09-08 | 17 |
| K932385 | Rocket of London, Ltd. | SUTURE REMOVING FORCEPS | 1993-08-06 | 81 |
| K904723 | Minto Research & Development, Inc. | FORCEPS | 1991-07-26 | 282 |
| K911159 | Northgate Technologies, Inc. | PALPATION PROBE | 1991-03-29 | 14 |
Recalls for GEN devices
10 product recalls in 8 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2024 | 4 |
Frequently asked questions
What is FDA product code GEN?
GEN is the FDA product code for forceps, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is GEN?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GEN?
Across 104 cleared submissions the average was 35 days from receipt to decision (median 25).
Which companies have the most GEN clearances?
Conphar, Inc. (14); The Huxley Instrument Corp. (8); Artiberia (6); Mill-Rose Laboratory (6); Edward Weck, Inc. (5).
Have GEN devices been recalled?
Yes: 10 product recalls across 8 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code GEN
- Run a recall and safety report across every GEN manufacturer
- Watch product code GEN 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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