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FDA 510(k)

SILICONE MALE EXTERNAL CATHETER

K-Number: K913524 · 1991-10-04

ApplicantMentor Corp.
Decision Date1991-10-04
Product CodeEXJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SILICONE MALE EXTERNAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1991-10-04 under 510(k) number K913524. 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 SILICONE MALE EXTERNAL CATHETER?

SILICONE MALE EXTERNAL CATHETER is a medical device that received FDA 510(k) clearance on 1991-10-04. The listed applicant is Mentor Corp.. The 510(k) number is K913524.

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

SILICONE MALE EXTERNAL CATHETER received FDA 510(k) clearance on 1991-10-04, under 510(k) number K913524.

Who is the listed applicant for SILICONE MALE EXTERNAL CATHETER?

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

What is the FDA product code for SILICONE MALE EXTERNAL CATHETER?

The FDA product code for SILICONE MALE EXTERNAL CATHETER is EXJ.

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Other records listing Mentor Corp. 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.

K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSK053414MENTOR NOVASILK MESHK050008MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KITK040959MENTOR GENESIS PENILE PROSTHESISK031767MENTOR OBTAPE TRANS-OBTURATOR TAPE

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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.K962384COMFORT SHEATH REUSABLE 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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