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FDA 510(k)

URINARY DRAINAGE BAG

K-Number: K934080 · 1994-05-18

ApplicantKit Pak, Inc.
Decision Date1994-05-18
Product CodeEYT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URINARY DRAINAGE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Kit Pak, Inc.. It received FDA 510(k) clearance on 1994-05-18 under 510(k) number K934080. 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 URINARY DRAINAGE BAG?

URINARY DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1994-05-18. The listed applicant is Kit Pak, Inc.. The 510(k) number is K934080.

When did URINARY DRAINAGE BAG receive FDA 510(k) clearance?

URINARY DRAINAGE BAG received FDA 510(k) clearance on 1994-05-18, under 510(k) number K934080.

Who is the listed applicant for URINARY DRAINAGE BAG?

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

What is the FDA product code for URINARY DRAINAGE BAG?

The FDA product code for URINARY DRAINAGE BAG is EYT.

Related Clinical Trials

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.

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Other records listing Kit Pak, 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.

K942959KIT PAK WET SALINE DRESSINGK941499KIT PAK DRESSING CHANGE TRAYK932310KIT PAK INCONTINENT SKIN CARE KITK931013FOLEY CATHETER TRAYK923905WOUND DRESSING KITK924051KIT PAK I.V. START KIT

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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.

K935774CURITY FAST-CATH FEMALE CATHETER KITKendall Healthcare Products Co. Div.Of Tyco HealthK883119VPI NON-ADHESIVE CONDOM CATHETERCook Urological, Inc.K883057COMFORT CATH 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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