FDA product code NML: Catheter, Biliary, Reprocessed
NML is the FDA product code for catheter, biliary, reprocessed. It is a Class II device, regulated under 21 CFR 876.5010 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under NML. The average 510(k) review took 264 days (median 264). FDA has posted 1 recall for NML devices.
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).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Biliary, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 876.5010 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NML clearance
Top NML applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sterilmed, Inc. | 1 | 2002-04-29 |
Most recent NML clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K012556 | Sterilmed, Inc. | REPROCESSED GUIDEWIRES | 2002-04-29 | 264 |
Recalls for NML devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-08-08.
Frequently asked questions
What is FDA product code NML?
NML is the FDA product code for catheter, biliary, reprocessed. It is a Class II device, regulated under 21 CFR 876.5010 and reviewed by the Gastroenterology and Urology panel.
What device class is NML?
Class II, regulation 21 CFR 876.5010. Typical premarket route: 510(k).
How long does a 510(k) take for product code NML?
Across 1 cleared submissions the average was 264 days from receipt to decision (median 264).
Which companies have the most NML clearances?
Sterilmed, Inc. (1).
Have NML devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-08-08.
Next steps
- Run an FDA pathway report with predicate devices for product code NML
- Run a recall and safety report across every NML manufacturer
- Watch product code NML for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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