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FDA 510(k)

CYTOCARE LASER CATHETER FOR UROLOGY

K-Number: K921708 · 1992-10-01

ApplicantCytocare, Inc.
Decision Date1992-10-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYTOCARE LASER CATHETER FOR UROLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Cytocare, Inc.. It received FDA 510(k) clearance on 1992-10-01 under 510(k) number K921708. 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 CYTOCARE LASER CATHETER FOR UROLOGY?

CYTOCARE LASER CATHETER FOR UROLOGY is a medical device that received FDA 510(k) clearance on 1992-10-01. The listed applicant is Cytocare, Inc.. The 510(k) number is K921708.

When did CYTOCARE LASER CATHETER FOR UROLOGY receive FDA 510(k) clearance?

CYTOCARE LASER CATHETER FOR UROLOGY received FDA 510(k) clearance on 1992-10-01, under 510(k) number K921708.

Who is the listed applicant for CYTOCARE LASER CATHETER FOR UROLOGY?

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

What is the FDA product code for CYTOCARE LASER CATHETER FOR UROLOGY?

The FDA product code for CYTOCARE LASER CATHETER FOR UROLOGY is GEX. This falls under the Gastroenterology category.

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Other records listing Cytocare, 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.

K954321ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION)K952698ENDOCARE ELECTROSURGICAL HANDPIECEK952587ENDOCARE MONOPOLAR ELECTRODESK942299ENDOCARE CRYOTHERAPY SYSTEMK945054ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEMK934211CYTOCARE DIODE LASER SYSTEM

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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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