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FDA 510(k)

SURGITEK NEPHROSTENT KIT

K-Number: K831446 · 1983-06-22

ApplicantMec/Surgitek Products
Decision Date1983-06-22
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGITEK NEPHROSTENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mec/Surgitek Products. It received FDA 510(k) clearance on 1983-06-22 under 510(k) number K831446. 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 NEPHROSTENT KIT?

SURGITEK NEPHROSTENT KIT is a medical device that received FDA 510(k) clearance on 1983-06-22. The listed applicant is Mec/Surgitek Products. The 510(k) number is K831446.

When did SURGITEK NEPHROSTENT KIT receive FDA 510(k) clearance?

SURGITEK NEPHROSTENT KIT received FDA 510(k) clearance on 1983-06-22, under 510(k) number K831446.

Who is the listed applicant for SURGITEK NEPHROSTENT KIT?

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

What is the FDA product code for SURGITEK NEPHROSTENT KIT?

The FDA product code for SURGITEK NEPHROSTENT KIT is FAD.

Related Clinical Trials

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.

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Other records listing Mec/Surgitek Products 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.

K830504SURGITEK ULTRA-LO CUFF

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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