GALILEO ARTHROSCOPES— 510(k) K934707

Substantially Equivalent

Galileo Electro-Optics Corp.

FDA 510(k) clearance K934707 for GALILEO ARTHROSCOPES, Substantially Equivalent on 1994-10-07. Applicant: Galileo Electro-Optics Corp..

Clearance details

Applicant: Galileo Electro-Optics Corp.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1993-09-30
Decision date: 1994-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sturbridge, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.