FDA product code FCI: Punch, Biopsy
FCI is the FDA product code for punch, biopsy. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under FCI, from 5 different applicants. The average 510(k) review took 79 days (median 78).
Classification
| Field | Value |
|---|---|
| Device name | Punch, Biopsy |
| Device class | Class II |
| Regulation | 21 CFR 876.1075 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FCI clearance
Top FCI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| National-Standard Co. | 1 | 1990-02-09 |
| Integrated Display Technology, Ltd. | 1 | 1989-10-23 |
| Advanced Diagnostic Medical Systems, Inc. | 1 | 1988-03-02 |
| August C. Stiefel Research Institute, Inc. | 1 | 1985-10-04 |
| Diasonics, Inc. | 1 | 1983-05-18 |
Most recent FCI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K895885 | National-Standard Co. | AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING | 1990-02-09 | 127 |
| K894627 | Integrated Display Technology, Ltd. | BT-338N ELECTRONIC CLINICAL THERMOMETER | 1989-10-23 | 91 |
| K875119 | Advanced Diagnostic Medical Systems, Inc. | BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE | 1988-03-02 | 78 |
| K853104 | August C. Stiefel Research Institute, Inc. | DISPOSABLE, STERILE BIOPSY PUNCH | 1985-10-04 | 73 |
| K831317 | Diasonics, Inc. | BIOPSY ATTACHMENT | 1983-05-18 | 26 |
Recalls for FCI devices
openFDA lists no recalls for product code FCI.
Frequently asked questions
What is FDA product code FCI?
FCI is the FDA product code for punch, biopsy. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel.
What device class is FCI?
Class II, regulation 21 CFR 876.1075. Typical premarket route: 510(k).
How long does a 510(k) take for product code FCI?
Across 5 cleared submissions the average was 79 days from receipt to decision (median 78).
Which companies have the most FCI clearances?
National-Standard Co. (1); Integrated Display Technology, Ltd. (1); Advanced Diagnostic Medical Systems, Inc. (1); August C. Stiefel Research Institute, Inc. (1); Diasonics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FCI
- Run a recall and safety report across every FCI manufacturer
- Watch product code FCI 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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