FDA 510(k)

SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT

K-Number: K913928 · 1991-11-19

ApplicantSurgitek Medical Engineering Corp.

Decision Date1991-11-19

Product CodeFAD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT 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 1991-11-19 under 510(k) number K913928. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT?

SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT is a medical device that received FDA 510(k) clearance on 1991-11-19. The listed applicant is Surgitek Medical Engineering Corp.. The 510(k) number is K913928.

When did SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT receive FDA 510(k) clearance?

SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT received FDA 510(k) clearance on 1991-11-19, under 510(k) number K913928.

Who is the listed applicant for SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT?

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) 4.5FR LUBRI-FLEX(TM) URETERAL STENT?

The FDA product code for SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT is FAD.

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Related Devices (Code: FAD)

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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.