FDA 510(k)

TRUCLEAR OPERATIVE HYSTEROSCOPE

K-Number: K112134 · 2011-11-22

Decision Date2011-11-22

Product CodeHIH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

TRUCLEAR OPERATIVE HYSTEROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2011-11-22 under 510(k) number K112134. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUCLEAR OPERATIVE HYSTEROSCOPE?

TRUCLEAR OPERATIVE HYSTEROSCOPE is a medical device that received FDA 510(k) clearance on 2011-11-22. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K112134.

When did TRUCLEAR OPERATIVE HYSTEROSCOPE receive FDA 510(k) clearance?

TRUCLEAR OPERATIVE HYSTEROSCOPE received FDA 510(k) clearance on 2011-11-22, under 510(k) number K112134.

Who is the listed applicant for TRUCLEAR OPERATIVE HYSTEROSCOPE?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUCLEAR OPERATIVE HYSTEROSCOPE?

The FDA product code for TRUCLEAR OPERATIVE HYSTEROSCOPE is HIH.

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Related Devices (Code: HIH)

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Official Source

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