Product code GCF— Gastroenterology, Urology
PROCTOSCOPE #501
- Classification name
- Proctoscope
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code GCF
FDA has cleared devices under product code GCF between 1979 and 1995, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1995
- 1979
Top applicants under product code GCF
Recent clearances under product code GCF
Data sourced from openFDA. This site is unofficial and independent of the FDA.