FDA 510(k)

SURGITEK SUPER DOUBLE J URETERAL STENT KIT

K-Number: K880660 · 1988-04-14

Decision Date1988-04-14

Product CodeFAD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SURGITEK SUPER DOUBLE J URETERAL STENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek. It received FDA 510(k) clearance on 1988-04-14 under 510(k) number K880660. 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 SUPER DOUBLE J URETERAL STENT KIT?

SURGITEK SUPER DOUBLE J URETERAL STENT KIT is a medical device that received FDA 510(k) clearance on 1988-04-14. The listed applicant is Surgitek. The 510(k) number is K880660.

When did SURGITEK SUPER DOUBLE J URETERAL STENT KIT receive FDA 510(k) clearance?

SURGITEK SUPER DOUBLE J URETERAL STENT KIT received FDA 510(k) clearance on 1988-04-14, under 510(k) number K880660.

Who is the listed applicant for SURGITEK SUPER DOUBLE J URETERAL STENT KIT?

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

What is the FDA product code for SURGITEK SUPER DOUBLE J URETERAL STENT KIT?

The FDA product code for SURGITEK SUPER DOUBLE J URETERAL STENT KIT is FAD.

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Other records listing Surgitek as applicant

K946296QUADRA-COIL URETERAL STENT K944391OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM K943491RIGHT ANGLE UROLOGIC LASER FIBER K941952SURGITEK INFUSER K933260HELICAL STONE/FLATWIRE STONE BASKETS K933261GRASPING FORCEPS

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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.