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FDA 510(k)

SLIP UROLOGY INTRODUCER SHEATH

K-Number: K040520 · 2004-05-20

ApplicantPercutaneous Systems, Inc.
Decision Date2004-05-20
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SLIP UROLOGY INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Percutaneous Systems, Inc.. It received FDA 510(k) clearance on 2004-05-20 under 510(k) number K040520. 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 SLIP UROLOGY INTRODUCER SHEATH?

SLIP UROLOGY INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 2004-05-20. The listed applicant is Percutaneous Systems, Inc.. The 510(k) number is K040520.

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

SLIP UROLOGY INTRODUCER SHEATH received FDA 510(k) clearance on 2004-05-20, under 510(k) number K040520.

Who is the listed applicant for SLIP UROLOGY INTRODUCER SHEATH?

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

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

The FDA product code for 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, 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.

K102887ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510K082803COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015K052134CYSTOGLIDE DILATING INTRODUCER SHEATHK042877MICROVERTER URETERAL ACCESS SHEATHK040519SLIP UROLOGY CATHETER

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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