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FDA 510(k)

CODMAN NEUROLASE LASER SYSTEM

K-Number: K872179 · 1987-10-07

ApplicantCodman & Shurtleff, Inc.
Decision Date1987-10-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CODMAN NEUROLASE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 1987-10-07 under 510(k) number K872179. 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 CODMAN NEUROLASE LASER SYSTEM?

CODMAN NEUROLASE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1987-10-07. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K872179.

When did CODMAN NEUROLASE LASER SYSTEM receive FDA 510(k) clearance?

CODMAN NEUROLASE LASER SYSTEM received FDA 510(k) clearance on 1987-10-07, under 510(k) number K872179.

Who is the listed applicant for CODMAN NEUROLASE LASER SYSTEM?

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

What is the FDA product code for CODMAN NEUROLASE LASER SYSTEM?

The FDA product code for CODMAN NEUROLASE LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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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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