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Laparoscopic Accessories, Gynecologic

FDA product code NWV · Class 1 · Obstetrics/Gynecology

557
Registered devices
508
Adverse events
7
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2020-03-17Applied Medical Resources CorpThere may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to
2020-03-17Applied Medical Resources CorpThere may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to
2020-03-17Applied Medical Resources CorpThere may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to
2020-03-17Applied Medical Resources CorpThere may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to
2017-04-25Cook Inc.reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
2015-12-01JosNoe Medical, Inc.Damage to package seals potentially compromising sterility.
2013-05-01Applied Medical Resources CorpApplied Medical is conducting a voluntary recall on specific lot numbers of its Epix and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activat

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.