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FDA 510(k)

QUADRA-COIL URETERAL STENT

K-Number: K946296 · 1995-03-06

ApplicantSurgitek
Decision Date1995-03-06
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

QUADRA-COIL URETERAL STENT is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek. It received FDA 510(k) clearance on 1995-03-06 under 510(k) number K946296. 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 QUADRA-COIL URETERAL STENT?

QUADRA-COIL URETERAL STENT is a medical device that received FDA 510(k) clearance on 1995-03-06. The listed applicant is Surgitek. The 510(k) number is K946296.

When did QUADRA-COIL URETERAL STENT receive FDA 510(k) clearance?

QUADRA-COIL URETERAL STENT received FDA 510(k) clearance on 1995-03-06, under 510(k) number K946296.

Who is the listed applicant for QUADRA-COIL URETERAL STENT?

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 QUADRA-COIL URETERAL STENT?

The FDA product code for QUADRA-COIL URETERAL STENT is FAD.

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Other records listing Surgitek as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K944391OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEMK943491RIGHT ANGLE UROLOGIC LASER FIBERK941952SURGITEK INFUSERK933260HELICAL STONE/FLATWIRE STONE BASKETSK933261GRASPING FORCEPSK930733URETERAL STENT

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Related Devices (Code: FAD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 CorporationK232920RELIEF™ 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.

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