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FDA 510(k)

GripMate

K-Number: K243232 · 2024-12-02

ApplicantSynthon Hispania S.L.
Decision Date2024-12-02
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GripMate is the device name listed in this FDA 510(k) record. The listed applicant is Synthon Hispania S.L.. It received FDA 510(k) clearance on 2024-12-02 under 510(k) number K243232. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GripMate?

GripMate is a medical device that received FDA 510(k) clearance on 2024-12-02. The listed applicant is Synthon Hispania S.L.. The 510(k) number is K243232.

When did GripMate receive FDA 510(k) clearance?

GripMate received FDA 510(k) clearance on 2024-12-02, under 510(k) number K243232.

Who is the listed applicant for GripMate?

The FDA 510(k) record lists Synthon Hispania S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GripMate?

The FDA product code for GripMate is KZH.

Related Devices (Code: KZH)

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.

K213429AccuSert Needle InserterEmed Technologies CorporationK163400Orbit InserterYpsomed AGK160860MiniMed Quick-serterMedtronic Minimed

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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