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FDA 510(k)

COMFORT CATH MALE EXTERNAL CATHETER

K-Number: K883057 · 1988-08-02

ApplicantSierra Laboratories, Inc.
Decision Date1988-08-02
Product CodeEYT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COMFORT CATH 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 1988-08-02 under 510(k) number K883057. The device is classified under product code EYT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORT CATH MALE EXTERNAL CATHETER?

COMFORT CATH MALE EXTERNAL CATHETER is a medical device that received FDA 510(k) clearance on 1988-08-02. The listed applicant is Sierra Laboratories, Inc.. The 510(k) number is K883057.

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

COMFORT CATH MALE EXTERNAL CATHETER received FDA 510(k) clearance on 1988-08-02, under 510(k) number K883057.

Who is the listed applicant for COMFORT CATH 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 CATH MALE EXTERNAL CATHETER?

The FDA product code for COMFORT CATH MALE EXTERNAL CATHETER is EYT.

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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 CATHETERK962384COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETERK934266COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETERK934052ALPINE REUSABLE LEG BAGSK931156CONE CATH

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Related Devices (Code: EYT)

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.

K934080URINARY DRAINAGE BAGKit Pak, Inc.K935774CURITY FAST-CATH FEMALE CATHETER KITKendall Healthcare Products Co. Div.Of Tyco HealthK883119VPI NON-ADHESIVE CONDOM CATHETERCook Urological, 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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