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FDA 510(k)

CODMAN LASER RODS

K-Number: K853627 · 1986-02-07

ApplicantCodman & Shurtleff, Inc.
Decision Date1986-02-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CODMAN LASER RODS 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 1986-02-07 under 510(k) number K853627. 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 LASER RODS?

CODMAN LASER RODS is a medical device that received FDA 510(k) clearance on 1986-02-07. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K853627.

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

CODMAN LASER RODS received FDA 510(k) clearance on 1986-02-07, under 510(k) number K853627.

Who is the listed applicant for CODMAN LASER RODS?

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 LASER RODS?

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

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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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