Cleared Special

SURGIFLATOR-20 ECU

K981859 · W.O.M. World of Medicine GmbH · Obstetrics & Gynecology
Jun 1998
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K981859 is an FDA 510(k) clearance for the SURGIFLATOR-20 ECU, a Insufflator, Laparoscopic (Class II — Special Controls, product code HIF), submitted by W.O.M. World of Medicine GmbH (Washington, US). The FDA issued a Cleared decision on June 26, 1998, 30 days after receiving the submission on May 27, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.

Submission Details

510(k) Number K981859 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 1998
Decision Date June 26, 1998
Days to Decision 30 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIF — Insufflator, Laparoscopic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1730

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