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FDA 510(k)

MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY

K-Number: K041995 · 2004-08-19

ApplicantUresil, LLC
Decision Date2004-08-19
Product CodeGBO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY is the device name listed in this FDA 510(k) record. The listed applicant is Uresil, LLC. It received FDA 510(k) clearance on 2004-08-19 under 510(k) number K041995. The device is classified under product code GBO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY?

MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY is a medical device that received FDA 510(k) clearance on 2004-08-19. The listed applicant is Uresil, LLC. The 510(k) number is K041995.

When did MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY receive FDA 510(k) clearance?

MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY received FDA 510(k) clearance on 2004-08-19, under 510(k) number K041995.

Who is the listed applicant for MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY?

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

What is the FDA product code for MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY?

The FDA product code for MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY is GBO.

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 Uresil, LLC 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.

K093653URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBKK053245GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER

Related Devices (Code: GBO)

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.

K021632GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE CUresil, L.P.K912109URESIL GENERAL PURPOSE DRAINAGE CATHETERUresil Corp.K854905PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE)Angiomed U.S., Inc.K854907PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)Angiomed U.S., Inc.K854911PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER)Angiomed U.S., Inc.K854909PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETSAngiomed U.S., Inc.

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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