FDA product code NLW: Electrode, Electrosurgical, Active, Urological, Reprocessed
NLW is the FDA product code for electrode, electrosurgical, active, urological, reprocessed. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under NLW. The average 510(k) review took 184 days (median 184). FDA has posted 1 recall for NLW devices.
Definition
The "electrode, electrosurgical, active, urological, reprocessed" is intended to be used endoscopically to contact urologic tissue so as to allow cutting, coagulation, electrodesiccation, or cautery dessication by means of electric current. This device is indicated for reuse/reprocessing. 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) 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 | Electrode, Electrosurgical, Active, Urological, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 876.4300 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NLW clearance
Top NLW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sterilmed, Inc. | 1 | 2002-02-14 |
Most recent NLW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K012685 | Sterilmed, Inc. | REPROCESSED ENDOSCOPIC ELECTRODES | 2002-02-14 | 184 |
Recalls for NLW 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 NLW?
NLW is the FDA product code for electrode, electrosurgical, active, urological, reprocessed. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.
What device class is NLW?
Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code NLW?
Across 1 cleared submissions the average was 184 days from receipt to decision (median 184).
Which companies have the most NLW clearances?
Sterilmed, Inc. (1).
Have NLW 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 NLW
- Run a recall and safety report across every NLW manufacturer
- Watch product code NLW 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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