FBW — Filiform And Filiform Follower Class I
FDA product code FBW covers "Filiform And Filiform Follower", a Class I medical device regulated under 21 CFR 876.5520. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification details
- Product Code
- FBW
- Device Class
- Class I
- Regulation Number
- 876.5520
- Submission Type
- 510(k) Exempt
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K912839 | Baxter Healthcare | LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE | Sep 25, 1991 |