Cleared Traditional

LAP-WAVE 3000 (P07)

K990732 · W.O.M. World of Medicine GmbH · Obstetrics & Gynecology
Jul 1999
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K990732 is an FDA 510(k) clearance for the LAP-WAVE 3000 (P07), a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by W.O.M. World of Medicine GmbH (Mansfield, US). The FDA issued a Cleared decision on July 23, 1999, 140 days after receiving the submission on March 5, 1999. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K990732 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1999
Decision Date July 23, 1999
Days to Decision 140 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HET — Laparoscope, Gynecologic (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1720

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