Endoscope, Flexible
The Endoscope, Flexible (product code GCQ) is a flexible fiberoptic or video endoscope designed to navigate the curves of internal body cavities, such as the gastrointestinal or urological tracts, for visual inspection, biopsy, or therapeutic intervention. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. The device is regulated under 21 CFR 876.1500 in the Gastroenterology, Urology specialty (GU). No special flags apply to this device.
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Basic Information
- Product Code
- GCQ
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K920979 | CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) | Mar 23, 1993 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K900894 | MEDILASE SERIES 2100 ENDOSCOPE | Jun 22, 1990 | Substantially Equivalent | Medical Laser, Inc. |
| K871978 | CODMAN FLEXIBLE ENDOSCOPE | Aug 25, 1987 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K864960 | TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. | Feb 10, 1987 | Substantially Equivalent | Cooper Lasersonics, Inc. |
| K860771 | VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE | Apr 23, 1986 | Substantially Equivalent | Van-Tec, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.