ULTRASONIC HAND INSTRUMENTS— 510(k) K971861
Substantially EquivalentUnited States Surgical, A Division of Tyco Healthc
FDA 510(k) clearance K971861 for ULTRASONIC HAND INSTRUMENTS, Substantially Equivalent on 1997-07-01. Applicant: United States Surgical, A Division of Tyco Healthc.
Clearance details
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Product code
- Code LFL
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norwalk, CT, US
Adverse events under product code LFL
product code LFL- Death
- 29
- Injury
- 1,046
- Malfunction
- 21,642
- Total
- 22,717
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.