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FDA 510(k)

UNIQUET

K-Number: K931198 · 1993-09-01

ApplicantIcat Systems
Decision Date1993-09-01
Product CodeGAX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNIQUET is the device name listed in this FDA 510(k) record. The listed applicant is Icat Systems. It received FDA 510(k) clearance on 1993-09-01 under 510(k) number K931198. The device is classified under product code GAX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIQUET?

UNIQUET is a medical device that received FDA 510(k) clearance on 1993-09-01. The listed applicant is Icat Systems. The 510(k) number is K931198.

When did UNIQUET receive FDA 510(k) clearance?

UNIQUET received FDA 510(k) clearance on 1993-09-01, under 510(k) number K931198.

Who is the listed applicant for UNIQUET?

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

What is the FDA product code for UNIQUET?

The FDA product code for UNIQUET is GAX.

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Related Devices (Code: GAX)

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.

K881398TOURNIQUETBarretta Products, Research and Development, Inc.K881176STERILE ESMARCH BANDAGESpectrum/Hydro-Med Products, Inc.K875092DEGANIA SILICONE TOURNIQUETDegania Silicone , Ltd.K873928UNIVERSAL TOURNIQUETDryden Corp.K872003KINDERWRAPThe Kinder Co.K864897DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335Dale Medical Products, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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