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FDA 510(k)

ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM

K-Number: K123553 · 2013-08-09

ApplicantZimmer, Inc.
Decision Date2013-08-09
Product CodeKCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2013-08-09 under 510(k) number K123553. 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 ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM?

ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-09. The listed applicant is Zimmer, Inc.. The 510(k) number is K123553.

When did ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM receive FDA 510(k) clearance?

ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM received FDA 510(k) clearance on 2013-08-09, under 510(k) number K123553.

Who is the listed applicant for ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM?

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

What is the FDA product code for ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM?

The FDA product code for ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM is KCY.

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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.K112874EZ VEIN INFLATABLE TOURNIQUETDominion Medical Devices, LLCK071140MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002Top Spins, Inc.K050411ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.K012632TOURNIQUET CUFF; PNEUMATIC TOURNIQUETMedical Instruments Technology, 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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