FDA product code NLL: Staple, Implantable, Reprocessed
NLL is the FDA product code for staple, implantable, reprocessed. It is a Class II device, regulated under 21 CFR 878.4750 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under NLL, from 2 different applicants. The average 510(k) review took 324 days (median 198).
Definition
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 | Staple, Implantable, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 878.4750 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Top NLL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sterilmed, Inc. | 2 | 2007-10-18 |
| Clearmedical, Inc. | 1 | 2005-07-11 |
Most recent NLL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070930 | Sterilmed, Inc. | REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS | 2007-10-18 | 198 |
| K070859 | Sterilmed, Inc. | REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS | 2007-09-12 | 168 |
| K033578 | Clearmedical, Inc. | REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS | 2005-07-11 | 606 |
Recalls for NLL devices
openFDA lists no recalls for product code NLL.
Frequently asked questions
What is FDA product code NLL?
NLL is the FDA product code for staple, implantable, reprocessed. It is a Class II device, regulated under 21 CFR 878.4750 and reviewed by the General and Plastic Surgery panel.
What device class is NLL?
Class II, regulation 21 CFR 878.4750. Typical premarket route: 510(k).
How long does a 510(k) take for product code NLL?
Across 3 cleared submissions the average was 324 days from receipt to decision (median 198).
Which companies have the most NLL clearances?
Sterilmed, Inc. (2); Clearmedical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NLL
- Run a recall and safety report across every NLL manufacturer
- Watch product code NLL 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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