SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK— 510(k) K935391
Substantially Equivalent3M Health Care, Sarns
FDA 510(k) clearance K935391 for SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK, Substantially Equivalent on 1994-02-24. Applicant: 3M Health Care, Sarns.
Clearance details
- Applicant
- 3M Health Care, Sarns
- Product code
- Code GFA
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Adverse events under product code GFA
product code GFA- Death
- 2
- Injury
- 140
- Malfunction
- 2,337
- Total
- 2,479
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.