Urethroscope
The Urethroscope is an endoscopic instrument used to directly visualize the urethra in the diagnosis and treatment of urethral conditions such as strictures, lesions, or foreign bodies. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FGC, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology medical specialty.
Research product code FGC in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- FGC
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K091600 | DIRECTVISION GUIDE SYSTEM | Aug 25, 2009 | Substantially Equivalent | Percuvision, LLC |
| K945907 | KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES | May 12, 1995 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K800913 | GYNECOLOGICAL CYSTO/URETHROSCOPE | May 14, 1980 | Substantially Equivalent | Kli |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.