THE GRIPPER— 510(k) K853422

Substantially Equivalent

Regional Master Corp.

FDA 510(k) clearance K853422 for THE GRIPPER, Substantially Equivalent on 1986-01-15. Applicant: Regional Master Corp..

Clearance details

Applicant: Regional Master Corp.
Product code: Code BXN
Advisory panel: Anesthesiology
Date received: 1985-08-14
Decision date: 1986-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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Adverse events under product code BXN

product code BXN

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.