FDA 510(k)

TRUCLEAR MORCELLATOR SYSTEM

K-Number: K110038 · 2011-03-30

Decision Date2011-03-30

Product CodeHIH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

TRUCLEAR MORCELLATOR SYSTEM 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 2011-03-30 under 510(k) number K110038. 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 MORCELLATOR SYSTEM?

TRUCLEAR MORCELLATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-30. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K110038.

When did TRUCLEAR MORCELLATOR SYSTEM receive FDA 510(k) clearance?

TRUCLEAR MORCELLATOR SYSTEM received FDA 510(k) clearance on 2011-03-30, under 510(k) number K110038.

Who is the listed applicant for TRUCLEAR MORCELLATOR SYSTEM?

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 MORCELLATOR SYSTEM?

The FDA product code for TRUCLEAR MORCELLATOR SYSTEM is 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.