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FDA 510(k)

URETERAL STENT

K-Number: K871667 · 1987-06-10

ApplicantPenn Medical Devices, Inc.
Decision Date1987-06-10
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETERAL STENT is the device name listed in this FDA 510(k) record. The listed applicant is Penn Medical Devices, Inc.. It received FDA 510(k) clearance on 1987-06-10 under 510(k) number K871667. 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 URETERAL STENT?

URETERAL STENT is a medical device that received FDA 510(k) clearance on 1987-06-10. The listed applicant is Penn Medical Devices, Inc.. The 510(k) number is K871667.

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

URETERAL STENT received FDA 510(k) clearance on 1987-06-10, under 510(k) number K871667.

Who is the listed applicant for URETERAL STENT?

The FDA 510(k) record lists Penn Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URETERAL STENT?

The FDA product code for URETERAL STENT is FAD.

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Other records listing Penn Medical Devices, Inc. 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.

K873949RORERTAZZI NASOPHARYNGEAL AIRWAYK873177DEVINE (SUPRAPUBIC SOUND AND GUIDE)K873176HUFFMAN BIOPSY UNITK873178URETERAL BULB DILATORSK870508GASTROINTESTINAL TUBEK862729PENN 3-RING HANDLE

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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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