FDA 510(k)

PNEUMOCLEAR

K-Number: K201361 · 2020-07-29

Decision Date2020-07-29

Product CodeHIF

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

PNEUMOCLEAR is a medical device manufactured by W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 2020-07-29 under approval number K201361. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PNEUMOCLEAR?

PNEUMOCLEAR is a medical device that received FDA 510(k) clearance on 2020-07-29. It is manufactured by W.O.M. World of Medicine GmbH. The 510(k) number is K201361.

When was PNEUMOCLEAR approved by the FDA?

PNEUMOCLEAR received FDA 510(k) clearance on 2020-07-29, under approval number K201361.

What company makes PNEUMOCLEAR?

PNEUMOCLEAR is manufactured by W.O.M. World of Medicine GmbH.

What is the FDA product code for PNEUMOCLEAR?

The FDA product code for PNEUMOCLEAR is HIF.

Other Devices by W.O.M. World of Medicine GmbH

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Related Devices (Code: HIF)

K162648U-Blade Veress NeedleTianjin Uwell Medical Device Manufacturing Co., Ltd. K153367S698 Symbioz flowSopro - Acteon Group K153513Insufflator 50L FM134W.O.M. World of Medicine GmbH K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC K162582HumiGard Surgical Humidification System, HumiGard Humdified Insufflation KitFisher & Paykel Healthcare K171139LaparoLight Veress NeedleBuffalo Filter, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.