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FDA 510(k)

SURGITEK INFUSER

K-Number: K941952 · 1994-05-24

ApplicantSurgitek
Decision Date1994-05-24
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGITEK INFUSER is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek. It received FDA 510(k) clearance on 1994-05-24 under 510(k) number K941952. 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 INFUSER?

SURGITEK INFUSER is a medical device that received FDA 510(k) clearance on 1994-05-24. The listed applicant is Surgitek. The 510(k) number is K941952.

When did SURGITEK INFUSER receive FDA 510(k) clearance?

SURGITEK INFUSER received FDA 510(k) clearance on 1994-05-24, under 510(k) number K941952.

Who is the listed applicant for SURGITEK INFUSER?

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 INFUSER?

The FDA product code for SURGITEK INFUSER 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.

K946296QUADRA-COIL URETERAL STENTK944391OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEMK943491RIGHT ANGLE UROLOGIC LASER FIBERK933261GRASPING FORCEPSK933260HELICAL STONE/FLATWIRE STONE BASKETSK930733URETERAL 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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