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FDA 510(k)

COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER

K-Number: K962384 · 1996-07-15

ApplicantSierra Laboratories, Inc.
Decision Date1996-07-15
Product CodeEXJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Sierra Laboratories, Inc.. It received FDA 510(k) clearance on 1996-07-15 under 510(k) number K962384. The device is classified under product code EXJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER?

COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER is a medical device that received FDA 510(k) clearance on 1996-07-15. The listed applicant is Sierra Laboratories, Inc.. The 510(k) number is K962384.

When did COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER receive FDA 510(k) clearance?

COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER received FDA 510(k) clearance on 1996-07-15, under 510(k) number K962384.

Who is the listed applicant for COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER?

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

What is the FDA product code for COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER?

The FDA product code for COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER is EXJ.

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 Sierra Laboratories, 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.

K970966COMFORT CATH CHOICE MALE EXTERNAL CATHETERK962413COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETERK934266COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETERK934052ALPINE REUSABLE LEG BAGSK931156CONE CATHK901000URO TEX URINALS

View all 12 devices →

Related Devices (Code: EXJ)

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.

K970465BOUSER'S URINALGeneral PolymersK972100VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)Advanced Care Medical ProductsK970966COMFORT CATH CHOICE MALE EXTERNAL CATHETERSierra Laboratories, Inc.K963265PROSYS SAMEC LAConvatec, A Division of E.R. Squibb & SonsK962900SELF RETAINING MALE EXTERNAL URINARY CATHETERHollister, Inc.K962413COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETERSierra Laboratories, Inc.

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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