FDA product code NMH: Laparoscope And Accessories, Gynecologic, Reprocessed

NMH is the FDA product code for laparoscope and accessories, gynecologic, reprocessed. It is a Class II device, regulated under 21 CFR 884.1720 and reviewed by the Obstetrics and Gynecology panel. Devices under NMH reach the market by 510(k); FDA lists no cleared 510(k)s for it.

Definition

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. 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

Recalls for NMH devices

openFDA lists no recalls for product code NMH.

Frequently asked questions

What is FDA product code NMH?

NMH is the FDA product code for laparoscope and accessories, gynecologic, reprocessed. It is a Class II device, regulated under 21 CFR 884.1720 and reviewed by the Obstetrics and Gynecology panel.

What device class is NMH?

Class II, regulation 21 CFR 884.1720. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code NMH
• Run a recall and safety report across every NMH manufacturer
• Watch product code NMH 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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