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FDA 510(k)

TOURNIQUET

K-Number: K813231 · 1981-12-14

ApplicantAspen Laboratories, Inc.
Decision Date1981-12-14
Product CodeKCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TOURNIQUET is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Laboratories, Inc.. It received FDA 510(k) clearance on 1981-12-14 under 510(k) number K813231. 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 TOURNIQUET?

TOURNIQUET is a medical device that received FDA 510(k) clearance on 1981-12-14. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K813231.

When did TOURNIQUET receive FDA 510(k) clearance?

TOURNIQUET received FDA 510(k) clearance on 1981-12-14, under 510(k) number K813231.

Who is the listed applicant for TOURNIQUET?

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

What is the FDA product code for TOURNIQUET?

The FDA product code for TOURNIQUET is KCY.

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Other records listing Aspen Laboratories, Inc. as applicant

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K981220SYSTEM 7500 ABC ELECTROSURGICAL UNITK963088SHEATH, ELECTROSURGICAL PENCILK955834SYSTEM 6500 ABC ELECTROSURGICAL UNITK9602964000 ETMK953081BEAMER PLUSK953007EXCALIBUR PLUS ELECTROSURGICAL UNIT

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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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