FDA 510(k)

SURGITEK URINARY DIVERSION STENT

K-Number: K800109 · 1980-02-26

Decision Date1980-02-26

Product CodeFAD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SURGITEK URINARY DIVERSION STENT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Engineering Corp.. It received FDA 510(k) clearance on 1980-02-26 under 510(k) number K800109. 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 URINARY DIVERSION STENT?

SURGITEK URINARY DIVERSION STENT is a medical device that received FDA 510(k) clearance on 1980-02-26. The listed applicant is Medical Engineering Corp.. The 510(k) number is K800109.

When did SURGITEK URINARY DIVERSION STENT receive FDA 510(k) clearance?

SURGITEK URINARY DIVERSION STENT received FDA 510(k) clearance on 1980-02-26, under 510(k) number K800109.

Who is the listed applicant for SURGITEK URINARY DIVERSION STENT?

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

What is the FDA product code for SURGITEK URINARY DIVERSION STENT?

The FDA product code for SURGITEK URINARY DIVERSION STENT is FAD.

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Other records listing Medical Engineering Corp. as applicant

K934141STAND ALONE CYSTOMETROGRAM K905289SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT K903448SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER K902773SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET K884746SURGITEK FLAT T-SPAN K883274SURGITEK (R) UROFLOW SYSTEM

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Related Devices (Code: FAD)

K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd.K251469Endura™ Ureteral Stent and Stent SetCathegenix (Xiamen) Co., Ltd.K243039Ureteral Stents (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.K243830Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd.K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent SetBoston Scientific Corporation K232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company

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.