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FDA 510(k)

AQUILEX FLUID CONTROL SYSTEM H112

K-Number: K112642 · 2012-02-06

ApplicantW.O.M. World of Medicine AG
Decision Date2012-02-06
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AQUILEX FLUID CONTROL SYSTEM H112 is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine AG. It received FDA 510(k) clearance on 2012-02-06 under 510(k) number K112642. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUILEX FLUID CONTROL SYSTEM H112?

AQUILEX FLUID CONTROL SYSTEM H112 is a medical device that received FDA 510(k) clearance on 2012-02-06. The listed applicant is W.O.M. World of Medicine AG. The 510(k) number is K112642.

When did AQUILEX FLUID CONTROL SYSTEM H112 receive FDA 510(k) clearance?

AQUILEX FLUID CONTROL SYSTEM H112 received FDA 510(k) clearance on 2012-02-06, under 510(k) number K112642.

Who is the listed applicant for AQUILEX FLUID CONTROL SYSTEM H112?

The FDA 510(k) record lists W.O.M. World of Medicine AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUILEX FLUID CONTROL SYSTEM H112?

The FDA product code for AQUILEX FLUID CONTROL SYSTEM H112 is HIG.

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Other records listing W.O.M. World of Medicine AG as applicant

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K123732HYSTEROSCOPY PUMP HM6K06336745L CORE INSUFFLATOR, MODEL F114K062380FLOSIMPLE ARTHROSCOPY PUMP A120K06072340 L HIGH FLOW INSUFFLATOR F113K042457URO PROK03083740 L HIGH FLOW INSUFFLATOR F108

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Related Devices (Code: HIG)

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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.

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