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FDA 510(k)

RocaJJ Soft Stents

K-Number: K173734 · 2018-03-12

ApplicantPromepla Sam
Decision Date2018-03-12
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RocaJJ Soft Stents is the device name listed in this FDA 510(k) record. The listed applicant is Promepla Sam. It received FDA 510(k) clearance on 2018-03-12 under 510(k) number K173734. 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 RocaJJ Soft Stents?

RocaJJ Soft Stents is a medical device that received FDA 510(k) clearance on 2018-03-12. The listed applicant is Promepla Sam. The 510(k) number is K173734.

When did RocaJJ Soft Stents receive FDA 510(k) clearance?

RocaJJ Soft Stents received FDA 510(k) clearance on 2018-03-12, under 510(k) number K173734.

Who is the listed applicant for RocaJJ Soft Stents?

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

What is the FDA product code for RocaJJ Soft Stents?

The FDA product code for RocaJJ Soft Stents is FAD.

Other records listing Promepla Sam as applicant

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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

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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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