NMLClass II
Catheter, Biliary, Reprocessed
21 CFR 876.5010 / Gastroenterology, Urology
NML is the FDA product code for Catheter, Biliary, Reprocessed, a class II device type, regulated under 21 CFR 876.5010. FDA's definition for this code reads: "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)". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.
Classification record
- Product code
- NML
- Device name
- Catheter, Biliary, Reprocessed
- FDA 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).
- Regulation
- 21 CFR 876.5010
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 1
Clearances, product code NML
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2002 | 1 |
Applicants with the most clearances
Product code NML| Applicant | Clearances |
|---|---|
| Sterilmed Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code NML.
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