Cleared Traditional

PNEUMOCLEAR

K201361 · W.O.M. World of Medicine GmbH · Obstetrics & Gynecology
Jul 2020
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K201361 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 July 29, 2020, 68 days after receiving the submission on May 22, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.

Submission Details

510(k) Number K201361 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2020
Decision Date July 29, 2020
Days to Decision 68 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

Similar Devices — HIF Insufflator, Laparoscopic

All 175
ENDOFLATOR +
K250388 · Karl Storz SE & CO. KG · Sep 2025
AirSurgN Insufflator (10030/AirSurgN)
K242772 · Smartsurgn, Inc. · Apr 2025
High Flow Insufflation Unit (UHI-4)
K243527 · Olympus Medical Systems Corporation · Jan 2025
TauTona Pneumoperitoneum Assist Device (TPAD)
K242536 · Tautona Group · Oct 2024
VereSee Optical Veres Needle System
K232464 · Freyja Healthcare, LLC · May 2024
EVA15 insufflator
K232902 · Palliare , Ltd. · May 2024