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FDA 510(k)

LASER FIBER DELIVERY/CLEANING CATHETER

K-Number: K960768 · 1996-05-14

ApplicantCook Urological, Inc.
Decision Date1996-05-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER FIBER DELIVERY/CLEANING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1996-05-14 under 510(k) number K960768. 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 LASER FIBER DELIVERY/CLEANING CATHETER?

LASER FIBER DELIVERY/CLEANING CATHETER is a medical device that received FDA 510(k) clearance on 1996-05-14. The listed applicant is Cook Urological, Inc.. The 510(k) number is K960768.

When did LASER FIBER DELIVERY/CLEANING CATHETER receive FDA 510(k) clearance?

LASER FIBER DELIVERY/CLEANING CATHETER received FDA 510(k) clearance on 1996-05-14, under 510(k) number K960768.

Who is the listed applicant for LASER FIBER DELIVERY/CLEANING CATHETER?

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

What is the FDA product code for LASER FIBER DELIVERY/CLEANING CATHETER?

The FDA product code for LASER FIBER DELIVERY/CLEANING CATHETER is GEX. This falls under the Gastroenterology category.

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Other records listing Cook Urological, Inc. as applicant

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Related Devices (Code: GEX)

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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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