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FDA 510(k)

MYOSURE INTRUMENT TRAY

K-Number: K121280 · 2013-02-08

ApplicantHologic, Inc.
Decision Date2013-02-08
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MYOSURE INTRUMENT TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2013-02-08 under 510(k) number K121280. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOSURE INTRUMENT TRAY?

MYOSURE INTRUMENT TRAY is a medical device that received FDA 510(k) clearance on 2013-02-08. The listed applicant is Hologic, Inc.. The 510(k) number is K121280.

When did MYOSURE INTRUMENT TRAY receive FDA 510(k) clearance?

MYOSURE INTRUMENT TRAY received FDA 510(k) clearance on 2013-02-08, under 510(k) number K121280.

Who is the listed applicant for MYOSURE INTRUMENT TRAY?

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 INTRUMENT TRAY?

The FDA product code for MYOSURE INTRUMENT TRAY is KCT.

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Related Devices (Code: KCT)

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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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