510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NMHClass II

Laparoscope And Accessories, Gynecologic, Reprocessed

21 CFR 884.1720 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

NMH is the FDA product code for Laparoscope And Accessories, Gynecologic, Reprocessed, a class II device type, regulated under 21 CFR 884.1720. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NMH
Device name
Laparoscope And Accessories, Gynecologic, Reprocessed
FDA 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).
Regulation
21 CFR 884.1720
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code