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FDA 510(k)

CYSTOGLIDE DILATING INTRODUCER SHEATH

K-Number: K052134 · 2005-09-22

ApplicantPercutaneous Systems, Inc.
Decision Date2005-09-22
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CYSTOGLIDE DILATING 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 2005-09-22 under 510(k) number K052134. 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 CYSTOGLIDE DILATING INTRODUCER SHEATH?

CYSTOGLIDE DILATING INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 2005-09-22. The listed applicant is Percutaneous Systems, Inc.. The 510(k) number is K052134.

When did CYSTOGLIDE DILATING INTRODUCER SHEATH receive FDA 510(k) clearance?

CYSTOGLIDE DILATING INTRODUCER SHEATH received FDA 510(k) clearance on 2005-09-22, under 510(k) number K052134.

Who is the listed applicant for CYSTOGLIDE DILATING 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 CYSTOGLIDE DILATING INTRODUCER SHEATH?

The FDA product code for CYSTOGLIDE DILATING 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 - COA20015K042877MICROVERTER URETERAL ACCESS SHEATHK040519SLIP UROLOGY CATHETERK040520SLIP UROLOGY INTRODUCER SHEATH

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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