GripMate— 510(k) K243232

Substantially Equivalent

Synthon Hispania S.L.

FDA 510(k) clearance K243232 for GripMate, Substantially Equivalent on 2024-12-02. Applicant: Synthon Hispania S.L..

Clearance details

Applicant: Synthon Hispania S.L.
Product code: Code KZH
Advisory panel: General Hospital
Date received: 2024-10-09
Decision date: 2024-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sant Boi De Llobregat, ES

Download summary PDF View on FDA.gov ↗

Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.