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FDA 510(k)

4 SURE EXTERNAL MALE CATHETER

K-Number: K896726 · 1990-02-26

ApplicantThe Boston & Pacific Co., Inc.
Decision Date1990-02-26
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

4 SURE EXTERNAL MALE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is The Boston & Pacific Co., Inc.. It received FDA 510(k) clearance on 1990-02-26 under 510(k) number K896726. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4 SURE EXTERNAL MALE CATHETER?

4 SURE EXTERNAL MALE CATHETER is a medical device that received FDA 510(k) clearance on 1990-02-26. The listed applicant is The Boston & Pacific Co., Inc.. The 510(k) number is K896726.

When did 4 SURE EXTERNAL MALE CATHETER receive FDA 510(k) clearance?

4 SURE EXTERNAL MALE CATHETER received FDA 510(k) clearance on 1990-02-26, under 510(k) number K896726.

Who is the listed applicant for 4 SURE EXTERNAL MALE CATHETER?

The FDA 510(k) record lists The Boston & Pacific Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4 SURE EXTERNAL MALE CATHETER?

The FDA product code for 4 SURE EXTERNAL MALE CATHETER is KOD.

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 The Boston & Pacific Co., 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.

K8967284 SURE URINARY LEG BAGK8967274 SURE URINARY DRAIN BAGK8967254 SURE UROLOGICAL CATHETER

Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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