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FDA 510(k)

EXPRESSAIRE TORUNIQUET SYSTEM

K-Number: K955552 · 1996-01-05

ApplicantSmith & Nephew Richards, Inc.
Decision Date1996-01-05
Product CodeKCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EXPRESSAIRE TORUNIQUET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1996-01-05 under 510(k) number K955552. The device is classified under product code KCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPRESSAIRE TORUNIQUET SYSTEM?

EXPRESSAIRE TORUNIQUET SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-05. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K955552.

When did EXPRESSAIRE TORUNIQUET SYSTEM receive FDA 510(k) clearance?

EXPRESSAIRE TORUNIQUET SYSTEM received FDA 510(k) clearance on 1996-01-05, under 510(k) number K955552.

Who is the listed applicant for EXPRESSAIRE TORUNIQUET SYSTEM?

The FDA 510(k) record lists Smith & Nephew Richards, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXPRESSAIRE TORUNIQUET SYSTEM?

The FDA product code for EXPRESSAIRE TORUNIQUET SYSTEM is KCY.

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Other records listing Smith & Nephew Richards, 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.

K965224EMPOWER ANTERIOR DIRECT SCREWSK963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONK960444FINN ROD TO ROD CONNECTORK964163TRIMAX NAIL SYSTEMK962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTK963486REVISION HIP SYSTEM

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Related Devices (Code: KCY)

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.

K202919ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting , Ltd.K162365T-CuffTerumobct, Inc.K123553ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.K112874EZ VEIN INFLATABLE TOURNIQUETDominion Medical Devices, LLCK071140MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002Top Spins, Inc.K050411ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEMZimmer, 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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