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FDA 510(k)

ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM

K-Number: K945054 · 1994-11-28

ApplicantCytocare, Inc.
Decision Date1994-11-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cytocare, Inc.. It received FDA 510(k) clearance on 1994-11-28 under 510(k) number K945054. 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 ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM?

ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1994-11-28. The listed applicant is Cytocare, Inc.. The 510(k) number is K945054.

When did ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM receive FDA 510(k) clearance?

ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM received FDA 510(k) clearance on 1994-11-28, under 510(k) number K945054.

Who is the listed applicant for ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM?

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 ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM?

The FDA product code for ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM 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 SYSTEMK934211CYTOCARE DIODE LASER SYSTEMK921708CYTOCARE LASER CATHETER FOR UROLOGY

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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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