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FDA 510(k)

MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL

K-Number: K122563 · 2012-09-19

ApplicantHologic, Inc.
Decision Date2012-09-19
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2012-09-19 under 510(k) number K122563. 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 XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL?

MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL is a medical device that received FDA 510(k) clearance on 2012-09-19. The listed applicant is Hologic, Inc.. The 510(k) number is K122563.

When did MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL receive FDA 510(k) clearance?

MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL received FDA 510(k) clearance on 2012-09-19, under 510(k) number K122563.

Who is the listed applicant for MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL?

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 XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL?

The FDA product code for MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL 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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