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FDA 510(k)

GYNCARE MORCELLEX TISSUE MORCELLATOR

K-Number: K100280 · 2010-03-24

ApplicantETHICON, Inc.
Decision Date2010-03-24
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYNCARE MORCELLEX TISSUE MORCELLATOR is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2010-03-24 under 510(k) number K100280. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNCARE MORCELLEX TISSUE MORCELLATOR?

GYNCARE MORCELLEX TISSUE MORCELLATOR is a medical device that received FDA 510(k) clearance on 2010-03-24. The listed applicant is ETHICON, Inc.. The 510(k) number is K100280.

When did GYNCARE MORCELLEX TISSUE MORCELLATOR receive FDA 510(k) clearance?

GYNCARE MORCELLEX TISSUE MORCELLATOR received FDA 510(k) clearance on 2010-03-24, under 510(k) number K100280.

Who is the listed applicant for GYNCARE MORCELLEX TISSUE MORCELLATOR?

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

What is the FDA product code for GYNCARE MORCELLEX TISSUE MORCELLATOR?

The FDA product code for GYNCARE MORCELLEX TISSUE MORCELLATOR is HET.

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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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