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FDA 510(k)

BOUSER'S URINAL

K-Number: K970465 · 1997-12-18

ApplicantGeneral Polymers
Decision Date1997-12-18
Product CodeEXJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BOUSER'S URINAL is the device name listed in this FDA 510(k) record. The listed applicant is General Polymers. It received FDA 510(k) clearance on 1997-12-18 under 510(k) number K970465. 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 BOUSER'S URINAL?

BOUSER'S URINAL is a medical device that received FDA 510(k) clearance on 1997-12-18. The listed applicant is General Polymers. The 510(k) number is K970465.

When did BOUSER'S URINAL receive FDA 510(k) clearance?

BOUSER'S URINAL received FDA 510(k) clearance on 1997-12-18, under 510(k) number K970465.

Who is the listed applicant for BOUSER'S URINAL?

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

What is the FDA product code for BOUSER'S URINAL?

The FDA product code for BOUSER'S URINAL 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.

K972100VENTED 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.K962413COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETERSierra Laboratories, Inc.

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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