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FDA 510(k)

SLIP UROLOGY CATHETER

K-Number: K040519 · 2004-05-20

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

Device Summary

SLIP UROLOGY CATHETER 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 K040519. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLIP UROLOGY CATHETER?

SLIP UROLOGY CATHETER 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 K040519.

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

SLIP UROLOGY CATHETER received FDA 510(k) clearance on 2004-05-20, under 510(k) number K040519.

Who is the listed applicant for SLIP UROLOGY CATHETER?

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 CATHETER?

The FDA product code for SLIP UROLOGY CATHETER is EZD.

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 - COA20015K052134CYSTOGLIDE DILATING INTRODUCER SHEATHK042877MICROVERTER URETERAL ACCESS SHEATHK040520SLIP UROLOGY INTRODUCER SHEATH

Related Devices (Code: EZD)

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.

K261418Liquick X-treme, Liquick X-treme PlusTeleflex MedicalK260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated

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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