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FDA 510(k)

MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)

K-Number: K131581 · 2013-08-22

ApplicantHologic, Inc.
Decision Date2013-08-22
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2013-08-22 under 510(k) number K131581. 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 MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)?

MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) is a medical device that received FDA 510(k) clearance on 2013-08-22. The listed applicant is Hologic, Inc.. The 510(k) number is K131581.

When did MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) receive FDA 510(k) clearance?

MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) received FDA 510(k) clearance on 2013-08-22, under 510(k) number K131581.

Who is the listed applicant for MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)?

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

What is the FDA product code for MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)?

The FDA product code for MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) is HIH.

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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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