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FDA 510(k)

UROPASS URETERAL ACCESS SHEATH, MODEL 61224

K-Number: K051593 · 2005-09-02

ApplicantAcmi Corporation
Decision Date2005-09-02
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROPASS URETERAL ACCESS SHEATH, MODEL 61224 is the device name listed in this FDA 510(k) record. The listed applicant is Acmi Corporation. It received FDA 510(k) clearance on 2005-09-02 under 510(k) number K051593. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROPASS URETERAL ACCESS SHEATH, MODEL 61224?

UROPASS URETERAL ACCESS SHEATH, MODEL 61224 is a medical device that received FDA 510(k) clearance on 2005-09-02. The listed applicant is Acmi Corporation. The 510(k) number is K051593.

When did UROPASS URETERAL ACCESS SHEATH, MODEL 61224 receive FDA 510(k) clearance?

UROPASS URETERAL ACCESS SHEATH, MODEL 61224 received FDA 510(k) clearance on 2005-09-02, under 510(k) number K051593.

Who is the listed applicant for UROPASS URETERAL ACCESS SHEATH, MODEL 61224?

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

What is the FDA product code for UROPASS URETERAL ACCESS SHEATH, MODEL 61224?

The FDA product code for UROPASS URETERAL ACCESS SHEATH, MODEL 61224 is KNY.

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Other records listing Acmi Corporation 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.

K061975PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PKK060752ACMI DUR-HL LASER SYSTEMSK060269ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEMK052044ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6ALK043581DUAL LUMEN CATHETERK042069INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM

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Related Devices (Code: KNY)

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.

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K182144Bi-Flex EvoPromepla SamK162356Vesair Cystoscopic SheathSolace TherapeuticsK131803GUARDIAN URETHRAL SHEATHSolace TherapeuticsK123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies AmericaK120160ROCAMED ROCAUS PLATINUMPromepla Sam

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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