FDA product code FCK: Instrument, Biopsy, Suction
FCK is the FDA product code for instrument, biopsy, suction. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 13 510(k) submissions under FCK, from 8 different applicants. The average 510(k) review took 125 days (median 97). FDA has posted 1 recall for FCK devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Biopsy, Suction |
| 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 |
510(k) clearances per year for FCK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 463 |
Compare with all 510(k) review times · Search every FCK clearance
Top FCK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| United States Endoscopy Group, Inc. | 4 | 2011-04-06 |
| Wilson-Cook Medical, Inc. | 2 | 2017-04-06 |
| Triton Technology, Inc. | 2 | 1993-09-24 |
| Aus Systems Pty , Ltd. | 1 | 2006-09-05 |
| Biopsys Medical, Inc. | 1 | 1994-12-05 |
3 more applicants have FCK clearances. See the full list in Caduvo.
Most recent FCK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153763 | Wilson-Cook Medical, Inc. | Howell Biliary Aspiration Needle | 2017-04-06 | 463 |
| K103326 | United States Endoscopy Group, Inc. | MULTIPLE BIOPSY SYSTEM | 2011-04-06 | 145 |
| K062159 | Aus Systems Pty , Ltd. | RB12 SUCTION RECTAL BIOPSY SYSTEM | 2006-09-05 | 39 |
| K061201 | United States Endoscopy Group, Inc. | DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 | 2006-05-30 | 29 |
| K051637 | United States Endoscopy Group, Inc. | DSNARE, MODEL 00711087 | 2005-10-31 | 133 |
Recalls for FCK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-11-03.
Frequently asked questions
What is FDA product code FCK?
FCK is the FDA product code for instrument, biopsy, suction. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel.
What device class is FCK?
Class II, regulation 21 CFR 876.1075. Typical premarket route: 510(k).
How long does a 510(k) take for product code FCK?
Across 13 cleared submissions the average was 125 days from receipt to decision (median 97).
Which companies have the most FCK clearances?
United States Endoscopy Group, Inc. (4); Wilson-Cook Medical, Inc. (2); Triton Technology, Inc. (2); Aus Systems Pty , Ltd. (1); Biopsys Medical, Inc. (1).
Have FCK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code FCK
- Run a recall and safety report across every FCK manufacturer
- Watch product code FCK 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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