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FDA 510(k)

U-TEX

K-Number: K955810 · 1996-01-24

ApplicantLaborie Medical Technologies, Ltd.
Decision Date1996-01-24
Product CodeFHA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

U-TEX is the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Technologies, Ltd.. It received FDA 510(k) clearance on 1996-01-24 under 510(k) number K955810. The device is classified under product code FHA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U-TEX?

U-TEX is a medical device that received FDA 510(k) clearance on 1996-01-24. The listed applicant is Laborie Medical Technologies, Ltd.. The 510(k) number is K955810.

When did U-TEX receive FDA 510(k) clearance?

U-TEX received FDA 510(k) clearance on 1996-01-24, under 510(k) number K955810.

Who is the listed applicant for U-TEX?

The FDA 510(k) record lists Laborie Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U-TEX?

The FDA product code for U-TEX is FHA.

Other records listing Laborie Medical Technologies, Ltd. 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.

K090830LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIPK962009UROSTYMK955856TEX-AID BLUEK951805PIPER, MODEL NUMBER UDS-PIPERBK942563ELITE BIOFEEDBACKK942023INFUSION PUMP, MODEL NO. UDP-5

View all 11 devices →

Related Devices (Code: FHA)

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.

K974040C3 EXTERNAL MALE BLADDER CONTROL DEVICETimm Research Co.K971992UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)Uromed Corp.K970308MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCEMentor Urology, Inc.K964580CAP-AID (IMPROVED)Nebel, Inc.K954959CAP-AIDNebl, Inc.K952841THE ASSISTANTApple Medical Corp.

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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