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FDA 510(k)

CYSTOGLIDE INTRODUCER SHEATH

K-Number: K052298 · 2006-12-12

ApplicantPercutaneous Systems, Incorporated
Decision Date2006-12-12
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CYSTOGLIDE 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 2006-12-12 under 510(k) number K052298. 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 INTRODUCER SHEATH?

CYSTOGLIDE INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 2006-12-12. The listed applicant is Percutaneous Systems, Incorporated. The 510(k) number is K052298.

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

CYSTOGLIDE INTRODUCER SHEATH received FDA 510(k) clearance on 2006-12-12, under 510(k) number K052298.

Who is the listed applicant for CYSTOGLIDE 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 CYSTOGLIDE INTRODUCER SHEATH?

The FDA product code for CYSTOGLIDE 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, 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 CATHETERK052048ACCORDIONK042531UPDATED SLIP 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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