FDA product code NWV: Laparoscopic Accessories, Gynecologic
NWV is the FDA product code for laparoscopic accessories, gynecologic. It is a Class I device, regulated under 21 CFR 884.1720 and reviewed by the Obstetrics and Gynecology panel. Devices under NWV reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 7 recalls for NWV devices.
Definition
Exempt laparoscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.
Classification
| Field | Value |
|---|---|
| Device name | Laparoscopic Accessories, Gynecologic |
| Device class | Class I |
| Regulation | 21 CFR 884.1720 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for NWV devices
7 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-03-17.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2020 | 4 |
Frequently asked questions
What is FDA product code NWV?
NWV is the FDA product code for laparoscopic accessories, gynecologic. It is a Class I device, regulated under 21 CFR 884.1720 and reviewed by the Obstetrics and Gynecology panel.
What device class is NWV?
Class I, regulation 21 CFR 884.1720. Typical premarket route: 510(k) exempt.
Have NWV devices been recalled?
Yes: 7 product recalls across 4 recall events; the most recent began 2020-03-17.
Next steps
- Run an FDA pathway report with predicate devices for product code NWV
- Run a recall and safety report across every NWV manufacturer
- Watch product code NWV 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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