GDS — Bag, Stomal Class I
FDA product code GDS covers "Bag, Stomal", a Class I medical device regulated under 21 CFR 876.5900. 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
- GDS
- Device Class
- Class I
- Regulation Number
- 876.5900
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No