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FDA 510(k)

GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY

K-Number: K850285 · 1985-02-28

ApplicantPremium Plastics, Inc.
Decision Date1985-02-28
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Premium Plastics, Inc.. It received FDA 510(k) clearance on 1985-02-28 under 510(k) number K850285. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY?

GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY is a medical device that received FDA 510(k) clearance on 1985-02-28. The listed applicant is Premium Plastics, Inc.. The 510(k) number is K850285.

When did GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY receive FDA 510(k) clearance?

GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY received FDA 510(k) clearance on 1985-02-28, under 510(k) number K850285.

Who is the listed applicant for GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY?

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

What is the FDA product code for GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY?

The FDA product code for GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY is KOD.

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Other records listing Premium Plastics, 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.

K953226PULM O2 SUCTION CATHETER TRAYSK950851GENT-L-KARE TRACHEOSTOMY TRAYSK950850GENT-L-KARE LACERATION TRAYSK943740ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)K890107GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KITK893135GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER

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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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