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FDA 510(k)

AM CATH ESWL STENT

K-Number: K864669 · 1987-01-05

ApplicantInter-Med Corp.
Decision Date1987-01-05
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AM CATH ESWL STENT is the device name listed in this FDA 510(k) record. The listed applicant is Inter-Med Corp.. It received FDA 510(k) clearance on 1987-01-05 under 510(k) number K864669. 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 AM CATH ESWL STENT?

AM CATH ESWL STENT is a medical device that received FDA 510(k) clearance on 1987-01-05. The listed applicant is Inter-Med Corp.. The 510(k) number is K864669.

When did AM CATH ESWL STENT receive FDA 510(k) clearance?

AM CATH ESWL STENT received FDA 510(k) clearance on 1987-01-05, under 510(k) number K864669.

Who is the listed applicant for AM CATH ESWL STENT?

The FDA 510(k) record lists Inter-Med Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AM CATH ESWL STENT?

The FDA product code for AM CATH ESWL STENT is FAD.

Related Clinical Trials

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Other records listing Inter-Med Corp. 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.

K871291AM CATH ESWL STENTK851922URETERAL STONE DISLODGERK833058GEN. PURPOSE INSTRUMENT TRAYS &

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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