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

Laparoscopic Accessories, Gynecologic

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

NWV is the FDA product code for Laparoscopic Accessories, Gynecologic, a class I device type, regulated under 21 CFR 884.1720. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and 7 recalls.

Classification record

Product code
NWV
Device name
Laparoscopic Accessories, Gynecologic
FDA 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.
Regulation
21 CFR 884.1720
Device class
Class I
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 73 companies shown, in name order