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FDA 510(k)

MICROSURGE LASER FIBER HOLDER

K-Number: K912332 · 1991-08-21

ApplicantMicrosurge, Inc.
Decision Date1991-08-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROSURGE LASER FIBER HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Microsurge, Inc.. It received FDA 510(k) clearance on 1991-08-21 under 510(k) number K912332. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSURGE LASER FIBER HOLDER?

MICROSURGE LASER FIBER HOLDER is a medical device that received FDA 510(k) clearance on 1991-08-21. The listed applicant is Microsurge, Inc.. The 510(k) number is K912332.

When did MICROSURGE LASER FIBER HOLDER receive FDA 510(k) clearance?

MICROSURGE LASER FIBER HOLDER received FDA 510(k) clearance on 1991-08-21, under 510(k) number K912332.

Who is the listed applicant for MICROSURGE LASER FIBER HOLDER?

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

What is the FDA product code for MICROSURGE LASER FIBER HOLDER?

The FDA product code for MICROSURGE LASER FIBER HOLDER is GEX. This falls under the Gastroenterology category.

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Other records listing Microsurge, Inc. as applicant

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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.

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