FDA 510(k)

TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS

K-Number: K132015 · 2013-12-13

Decision Date2013-12-13

Product CodeHIH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS 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 2013-12-13 under 510(k) number K132015. 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 MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS?

TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS is a medical device that received FDA 510(k) clearance on 2013-12-13. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K132015.

When did TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS receive FDA 510(k) clearance?

TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS received FDA 510(k) clearance on 2013-12-13, under 510(k) number K132015.

Who is the listed applicant for TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS?

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 MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS?

The FDA product code for TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS 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.