CO2 FOR ARTHROSCOPY— 510(k) K852592

Substantially Equivalent

The Anspach Effort, Inc.

FDA 510(k) clearance K852592 for CO2 FOR ARTHROSCOPY, Substantially Equivalent on 1985-08-09. Applicant: The Anspach Effort, Inc..

Clearance details

Applicant
The Anspach Effort, Inc.
Product code
Code HRX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lake Park, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HRX

product code HRX
Injury
623
Malfunction
11,257
Total
11,880

Source: openFDA MAUDE database, through . 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.