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FDA 510(k)

HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER

K-Number: K940269 · 1994-06-02

ApplicantHollister, Inc.
Decision Date1994-06-02
Product CodeEXJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1994-06-02 under 510(k) number K940269. 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 HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER?

HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER is a medical device that received FDA 510(k) clearance on 1994-06-02. The listed applicant is Hollister, Inc.. The 510(k) number is K940269.

When did HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER receive FDA 510(k) clearance?

HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER received FDA 510(k) clearance on 1994-06-02, under 510(k) number K940269.

Who is the listed applicant for HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER?

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

What is the FDA product code for HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER?

The FDA product code for HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER is EXJ.

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Other records listing Hollister, 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.

K123804INSTAFLO BOWEL CATHETER SYSTEM KITK100273INSTAFLO BOWEL CATHETER SYSTEM KITK090960VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,K083153ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007K050483EVADRI BLADDER CONTROL SYSTEMSK040779RESTORE WOUND CLEANSER

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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.K962413COMFORT CATH SPECIAL SELF ADHERING 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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