NML — Catheter, Biliary, Reprocessed Class II
FDA product code NML covers "Catheter, Biliary, Reprocessed", a Class II medical device regulated under 21 CFR 876.5010. 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
- NML
- Device Class
- Class II
- Regulation Number
- 876.5010
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
same as "FGE" except being reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K012556 | sterilmed | REPROCESSED GUIDEWIRES | April 29, 2002 |