FDA product code FCL: Forceps, Biopsy, Non-Electric
FCL is the FDA product code for forceps, biopsy, non-electric. It is a Class I device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 39 510(k) submissions under FCL, from 29 different applicants. The average 510(k) review took 98 days (median 76). FDA has posted 11 recalls for FCL devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Biopsy, Non-Electric |
| Device class | Class I |
| Regulation | 21 CFR 876.1075 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FCL clearance
Top FCL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cox Medical Ent., Inc. | 3 | 1995-03-06 |
| Symbiosis Corp. | 3 | 1995-01-20 |
| C.R. Bard, Inc. | 3 | 1991-11-27 |
| Spectrascience, Inc. | 2 | 1997-12-02 |
| Portlyn Corp. | 2 | 1995-06-01 |
24 more applicants have FCL clearances. See the full list in Caduvo.
Most recent FCL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K032092 | Olympus Optical Co., Ltd. | OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE | 2003-07-16 | 9 |
| K973611 | Spectrascience, Inc. | SPECTRASCIENCE REUSABLE BIOPSY FORCEPS | 1997-12-02 | 71 |
| K971315 | Richard Wolf Medical Instruments Corp. | AUXILIARY INSTRUMENTS FOR URS | 1997-09-15 | 159 |
| K964120 | Robert J. Jynch, Jr. | INJECTO FLUSH | 1996-12-30 | 76 |
| K963517 | Spectrascience, Inc. | SPECTRA SCIENCE BIOPSY FORCEPS | 1996-12-02 | 90 |
Recalls for FCL devices
11 product recalls in 4 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2026-06-30.
| Year | Recalls |
|---|---|
| 2023 | 4 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code FCL?
FCL is the FDA product code for forceps, biopsy, non-electric. It is a Class I device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel.
What device class is FCL?
Class I, regulation 21 CFR 876.1075. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FCL?
Across 39 cleared submissions the average was 98 days from receipt to decision (median 76).
Which companies have the most FCL clearances?
Cox Medical Ent., Inc. (3); Symbiosis Corp. (3); C.R. Bard, Inc. (3); Spectrascience, Inc. (2); Portlyn Corp. (2).
Have FCL devices been recalled?
Yes: 11 product recalls across 4 recall events; the most recent began 2026-06-30.
Next steps
- Run an FDA pathway report with predicate devices for product code FCL
- Run a recall and safety report across every FCL manufacturer
- Watch product code FCL 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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