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FDA 510(k)

CATHETER, DISP., EXTERNAL, MALE

K-Number: K772144 · 1977-11-28

ApplicantMedline Industries, Inc.
Decision Date1977-11-28
Product CodeEXJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHETER, DISP., EXTERNAL, MALE is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 1977-11-28 under 510(k) number K772144. 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 CATHETER, DISP., EXTERNAL, MALE?

CATHETER, DISP., EXTERNAL, MALE is a medical device that received FDA 510(k) clearance on 1977-11-28. The listed applicant is Medline Industries, Inc.. The 510(k) number is K772144.

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

CATHETER, DISP., EXTERNAL, MALE received FDA 510(k) clearance on 1977-11-28, under 510(k) number K772144.

Who is the listed applicant for CATHETER, DISP., EXTERNAL, MALE?

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

What is the FDA product code for CATHETER, DISP., EXTERNAL, MALE?

The FDA product code for CATHETER, DISP., EXTERNAL, MALE is EXJ.

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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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