FDA product code FCF: Instrument, Biopsy, Mechanical, Gastrointestinal
FCF is the FDA product code for instrument, biopsy, mechanical, gastrointestinal. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under FCF, from 5 different applicants. The average 510(k) review took 134 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Biopsy, Mechanical, Gastrointestinal |
| 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 FCF clearance
Top FCF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vidacare Corporation | 2 | 2007-05-21 |
| United States Endoscopy Group, Inc. | 1 | 1999-12-07 |
| Intl. Medical, Inc. | 1 | 1992-01-10 |
| Endovations | 1 | 1991-08-07 |
| Zimmar Consulting , Ltd. | 1 | 1984-12-05 |
Most recent FCF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070759 | Vidacare Corporation | POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM | 2007-05-21 | 62 |
| K062833 | Vidacare Corporation | POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM | 2006-11-30 | 70 |
| K984168 | United States Endoscopy Group, Inc. | BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE | 1999-12-07 | 382 |
| K915142 | Intl. Medical, Inc. | AMCATH DISPOSABLE BIOPSY FORCEPS | 1992-01-10 | 57 |
| K911155 | Endovations | OVAL CUP BIOPSY FORCEP | 1991-08-07 | 145 |
Recalls for FCF devices
openFDA lists no recalls for product code FCF.
Frequently asked questions
What is FDA product code FCF?
FCF is the FDA product code for instrument, biopsy, mechanical, gastrointestinal. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel.
What device class is FCF?
Class II, regulation 21 CFR 876.1075. Typical premarket route: 510(k).
How long does a 510(k) take for product code FCF?
Across 6 cleared submissions the average was 134 days from receipt to decision (median 80).
Which companies have the most FCF clearances?
Vidacare Corporation (2); United States Endoscopy Group, Inc. (1); Intl. Medical, Inc. (1); Endovations (1); Zimmar Consulting , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FCF
- Run a recall and safety report across every FCF manufacturer
- Watch product code FCF 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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