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FDA 510(k)

UPDATED SLIP UROLOGY INTRODUCER SHEATH

K-Number: K042531 · 2005-02-01

ApplicantPercutaneous Systems, Incorporated
Decision Date2005-02-01
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UPDATED SLIP UROLOGY INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Percutaneous Systems, Incorporated. It received FDA 510(k) clearance on 2005-02-01 under 510(k) number K042531. 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 UPDATED SLIP UROLOGY INTRODUCER SHEATH?

UPDATED SLIP UROLOGY INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 2005-02-01. The listed applicant is Percutaneous Systems, Incorporated. The 510(k) number is K042531.

When did UPDATED SLIP UROLOGY INTRODUCER SHEATH receive FDA 510(k) clearance?

UPDATED SLIP UROLOGY INTRODUCER SHEATH received FDA 510(k) clearance on 2005-02-01, under 510(k) number K042531.

Who is the listed applicant for UPDATED SLIP UROLOGY INTRODUCER SHEATH?

The FDA 510(k) record lists Percutaneous Systems, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UPDATED SLIP UROLOGY INTRODUCER SHEATH?

The FDA product code for UPDATED SLIP UROLOGY INTRODUCER SHEATH is KNY.

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 Percutaneous Systems, Incorporated 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.

K090485COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003K061766EXPRESSWAY INTERMITTENT CATHETERK052298CYSTOGLIDE INTRODUCER SHEATHK052048ACCORDION

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

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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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