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FDA 510(k)

SURGITEK(R) TURP MONITOR

K-Number: K903127 · 1990-10-09

ApplicantSurgitek Medical Engineering Corp.
Decision Date1990-10-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGITEK(R) TURP MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek Medical Engineering Corp.. It received FDA 510(k) clearance on 1990-10-09 under 510(k) number K903127. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITEK(R) TURP MONITOR?

SURGITEK(R) TURP MONITOR is a medical device that received FDA 510(k) clearance on 1990-10-09. The listed applicant is Surgitek Medical Engineering Corp.. The 510(k) number is K903127.

When did SURGITEK(R) TURP MONITOR receive FDA 510(k) clearance?

SURGITEK(R) TURP MONITOR received FDA 510(k) clearance on 1990-10-09, under 510(k) number K903127.

Who is the listed applicant for SURGITEK(R) TURP MONITOR?

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

What is the FDA product code for SURGITEK(R) TURP MONITOR?

The FDA product code for SURGITEK(R) TURP MONITOR is GEI.

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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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