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FDA 510(k)

MORCELLEX SIGMA GENERATOR

K-Number: K131656 · 2013-09-27

ApplicantETHICON, Inc.
Decision Date2013-09-27
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MORCELLEX SIGMA GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2013-09-27 under 510(k) number K131656. 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 MORCELLEX SIGMA GENERATOR?

MORCELLEX SIGMA GENERATOR is a medical device that received FDA 510(k) clearance on 2013-09-27. The listed applicant is ETHICON, Inc.. The 510(k) number is K131656.

When did MORCELLEX SIGMA GENERATOR receive FDA 510(k) clearance?

MORCELLEX SIGMA GENERATOR received FDA 510(k) clearance on 2013-09-27, under 510(k) number K131656.

Who is the listed applicant for MORCELLEX SIGMA GENERATOR?

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 MORCELLEX SIGMA GENERATOR?

The FDA product code for MORCELLEX SIGMA GENERATOR 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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