FDA product code FSH: Tray, Surgical, Needle
FSH is the FDA product code for tray, surgical, needle. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under FSH, from 5 different applicants. The average 510(k) review took 36 days (median 29). FDA has posted 7 recalls for FSH devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tray, Surgical, Needle |
| 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 |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FSH clearance
Top FSH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Pharmaseal Div. Ahsc | 3 | 1982-01-28 |
| Carl Zeiss, Inc. | 2 | 1988-12-15 |
| Emerson-Sack-Warner Corp. | 1 | 1982-07-30 |
| Applied Medical Research | 1 | 1978-05-19 |
| Diagnostic Products Corp. | 1 | 1977-12-22 |
Most recent FSH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884876 | Carl Zeiss, Inc. | S 4 INSTRUMENT STAND | 1988-12-15 | 24 |
| K883578 | Carl Zeiss, Inc. | S 21 INSTRUMENT STAND | 1988-09-13 | 22 |
| K821921 | Emerson-Sack-Warner Corp. | STAND, SURG. INSTRUMENT & DRESSING | 1982-07-30 | 31 |
| K813338 | American Pharmaseal Div. Ahsc | BIOPSY NEEDLES & TRAYS | 1982-01-28 | 65 |
| K813337 | American Pharmaseal Div. Ahsc | SKINNY CHIBA NEEDLE & TRAY | 1982-01-28 | 65 |
Recalls for FSH devices
7 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-05-21.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2024 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FSH?
FSH is the FDA product code for tray, surgical, needle. 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 FSH?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FSH?
Across 8 cleared submissions the average was 36 days from receipt to decision (median 29).
Which companies have the most FSH clearances?
American Pharmaseal Div. Ahsc (3); Carl Zeiss, Inc. (2); Emerson-Sack-Warner Corp. (1); Applied Medical Research (1); Diagnostic Products Corp. (1).
Have FSH devices been recalled?
Yes: 7 product recalls across 3 recall events; the most recent began 2026-05-21.
Next steps
- Run an FDA pathway report with predicate devices for product code FSH
- Run a recall and safety report across every FSH manufacturer
- Watch product code FSH 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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