GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES— 510(k) K971781
Substantially EquivalentWilson Greatbatch Technologies, Inc.
FDA 510(k) clearance K971781 for GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES, Substantially Equivalent on 1997-11-21. Applicant: Wilson Greatbatch Technologies, Inc..
Clearance details
- Applicant
- Wilson Greatbatch Technologies, Inc.
- Product code
- Code HRX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clarence, NY, US
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.