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FDA 510(k)

TEX-AID BLUE

K-Number: K955856 · 1996-02-16

ApplicantLaborie Medical Technologies, Ltd.
Decision Date1996-02-16
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TEX-AID BLUE 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 1996-02-16 under 510(k) number K955856. The device is classified under product code LKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEX-AID BLUE?

TEX-AID BLUE is a medical device that received FDA 510(k) clearance on 1996-02-16. The listed applicant is Laborie Medical Technologies, Ltd.. The 510(k) number is K955856.

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

TEX-AID BLUE received FDA 510(k) clearance on 1996-02-16, under 510(k) number K955856.

Who is the listed applicant for TEX-AID BLUE?

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 TEX-AID BLUE?

The FDA product code for TEX-AID BLUE is LKY.

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 TIPK962009UROSTYMK955810U-TEXK951805PIPER, MODEL NUMBER UDS-PIPERBK942563ELITE BIOFEEDBACKK942023INFUSION PUMP, MODEL NO. UDP-5

View all 11 devices →

Related Devices (Code: LKY)

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.

K041573NANMA VACUUM PUMP PROXZEK MODEL 2M9498SNanma Mfg Co., Ltd.K032776VACURECT VACUUM CONSTRICTION DEVICEVacurect Manufacturing (Pty) , Ltd.K030119NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.K030913NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013113MODIFICATION TO NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013051NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., 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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