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FDA 510(k)

FOLEY INSERTION TRAY

K-Number: K923906 · 1993-06-22

ApplicantKit Pak, Inc.
Decision Date1993-06-22
Product CodeKOD
Advisory CommitteeGU
DecisionUnknown

Device Summary

FOLEY INSERTION TRAY 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 1993-06-22 under 510(k) number K923906. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the FOLEY INSERTION TRAY?

FOLEY INSERTION TRAY is a medical device that received FDA 510(k) clearance on 1993-06-22. The listed applicant is Kit Pak, Inc.. The 510(k) number is K923906.

When did FOLEY INSERTION TRAY receive FDA 510(k) clearance?

FOLEY INSERTION TRAY received FDA 510(k) clearance on 1993-06-22, under 510(k) number K923906.

Who is the listed applicant for FOLEY INSERTION TRAY?

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 FOLEY INSERTION TRAY?

The FDA product code for FOLEY INSERTION TRAY is KOD.

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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 KITK934080URINARY DRAINAGE BAGK931013FOLEY CATHETER TRAYK923905WOUND DRESSING KIT

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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