Cleared Traditional

PNEUMOCLEAR

K170784 · W.O.M. World of Medicine GmbH · Obstetrics & Gynecology
May 2017
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K170784 is an FDA 510(k) clearance for the PNEUMOCLEAR, a Insufflator, Laparoscopic (Class II — Special Controls, product code HIF), submitted by W.O.M. World of Medicine GmbH (Berlin, DE). The FDA issued a Cleared decision on May 15, 2017, 61 days after receiving the submission on March 15, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.

Submission Details

510(k) Number K170784 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2017
Decision Date May 15, 2017
Days to Decision 61 days
Submission Type Traditional
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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