FDA 510(k)

MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)

K-Number: K121868 · 2012-07-19

Decision Date2012-07-19

Product CodeHIH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (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 2012-07-19 under 510(k) number K121868. 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 LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)?

MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK) is a medical device that received FDA 510(k) clearance on 2012-07-19. The listed applicant is Hologic, Inc.. The 510(k) number is K121868.

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

MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK) received FDA 510(k) clearance on 2012-07-19, under 510(k) number K121868.

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

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

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Related Devices (Code: 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.