FEX — Instrument, Catheter, Punch Class I
FDA product code FEX covers "Instrument, Catheter, Punch", a Class I medical device regulated under 21 CFR 876.5090. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FEX
- Device Class
- Class I
- Regulation Number
- 876.5090
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No