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FDA 510(k)

MALE EXTERNAL CATHETER

K-Number: K923136 · 1992-12-03

ApplicantRochester Medical Corp.
Decision Date1992-12-03
Product CodeEXJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MALE EXTERNAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Rochester Medical Corp.. It received FDA 510(k) clearance on 1992-12-03 under 510(k) number K923136. 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 MALE EXTERNAL CATHETER?

MALE EXTERNAL CATHETER is a medical device that received FDA 510(k) clearance on 1992-12-03. The listed applicant is Rochester Medical Corp.. The 510(k) number is K923136.

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

MALE EXTERNAL CATHETER received FDA 510(k) clearance on 1992-12-03, under 510(k) number K923136.

Who is the listed applicant for MALE EXTERNAL CATHETER?

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

What is the FDA product code for MALE EXTERNAL CATHETER?

The FDA product code for MALE EXTERNAL CATHETER is EXJ.

Related Clinical Trials

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Other records listing Rochester Medical 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.

K122785HYDROSIL; MAGIC; PERSONAL CATHETERK033477HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KITK001143RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETERK000723HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)K981612ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETERK971627SILICONE ANTIBACTERIAL FOLEY CATHETER

View all 13 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.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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