Cleared Traditional

GripMate

K243232 · Synthon Hispania S.L. · General Hospital
Dec 2024
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K243232 is an FDA 510(k) clearance for the GripMate, a Introducer, Syringe Needle (Class II — Special Controls, product code KZH), submitted by Synthon Hispania S.L. (Sant Boi De Llobregat, ES). The FDA issued a Cleared decision on December 2, 2024, 54 days after receiving the submission on October 9, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6920.

Submission Details

510(k) Number K243232 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 2024
Decision Date December 02, 2024
Days to Decision 54 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KZH — Introducer, Syringe Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6920