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FDA 510(k)

CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER

K-Number: K951714 · 1995-07-11

ApplicantCabot Medical Corp.
Decision Date1995-07-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Cabot Medical Corp.. It received FDA 510(k) clearance on 1995-07-11 under 510(k) number K951714. 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 CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER?

CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER is a medical device that received FDA 510(k) clearance on 1995-07-11. The listed applicant is Cabot Medical Corp.. The 510(k) number is K951714.

When did CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER receive FDA 510(k) clearance?

CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER received FDA 510(k) clearance on 1995-07-11, under 510(k) number K951714.

Who is the listed applicant for CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER?

The FDA 510(k) record lists Cabot Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER?

The FDA product code for CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER is GEX. This falls under the Gastroenterology category.

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Other records listing Cabot Medical Corp. as applicant

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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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