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FDA 510(k)

MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

K-Number: K100559 · 2010-03-30

ApplicantInterlace Medical, Inc.
Decision Date2010-03-30
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Interlace Medical, Inc.. It received FDA 510(k) clearance on 2010-03-30 under 510(k) number K100559. 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 HYSTEROSCOPIC TISSUE REMOVAL SYSTEM?

MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM is a medical device that received FDA 510(k) clearance on 2010-03-30. The listed applicant is Interlace Medical, Inc.. The 510(k) number is K100559.

When did MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM receive FDA 510(k) clearance?

MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM received FDA 510(k) clearance on 2010-03-30, under 510(k) number K100559.

Who is the listed applicant for MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM?

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

What is the FDA product code for MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM?

The FDA product code for MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM is HIH.

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Other records listing Interlace Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K103741SURGISURE TISSUE REMOVAL SYSTEMK102686MYOSURE ROD LENS SCOPE SEALSK091100MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEMK091465MYOSURE ROD LENS HYSTEROSCOPEK081070INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEMK073690INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM

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Related Devices (Code: 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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