FDA product code GCQ: Endoscope, Flexible
GCQ is the FDA product code for endoscope, flexible. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under GCQ, from 4 different applicants. The average 510(k) review took 139 days (median 95). FDA has posted 22 recalls for GCQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Endoscope, Flexible |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every GCQ clearance
Top GCQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Codman & Shurtleff, Inc. | 2 | 1993-03-23 |
| Medical Laser, Inc. | 1 | 1990-06-22 |
| Cooper Lasersonics, Inc. | 1 | 1987-02-10 |
| Van-Tec, Inc. | 1 | 1986-04-23 |
Most recent GCQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920979 | Codman & Shurtleff, Inc. | CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) | 1993-03-23 | 386 |
| K900894 | Medical Laser, Inc. | MEDILASE SERIES 2100 ENDOSCOPE | 1990-06-22 | 115 |
| K871978 | Codman & Shurtleff, Inc. | CODMAN FLEXIBLE ENDOSCOPE | 1987-08-25 | 95 |
| K864960 | Cooper Lasersonics, Inc. | TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. | 1987-02-10 | 50 |
| K860771 | Van-Tec, Inc. | VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE | 1986-04-23 | 51 |
Recalls for GCQ devices
22 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-01-20.
Frequently asked questions
What is FDA product code GCQ?
GCQ is the FDA product code for endoscope, flexible. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is GCQ?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code GCQ?
Across 5 cleared submissions the average was 139 days from receipt to decision (median 95).
Which companies have the most GCQ clearances?
Codman & Shurtleff, Inc. (2); Medical Laser, Inc. (1); Cooper Lasersonics, Inc. (1); Van-Tec, Inc. (1).
Have GCQ devices been recalled?
Yes: 22 product recalls across 1 recall events; the most recent began 2016-01-20.
Next steps
- Run an FDA pathway report with predicate devices for product code GCQ
- Run a recall and safety report across every GCQ manufacturer
- Watch product code GCQ 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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