SUTURE CLIP REMOVER— 510(k) K771640
Substantially EquivalentUnited States Surgical, A Division of Tyco Healthc
FDA 510(k) clearance K771640 for SUTURE CLIP REMOVER, Substantially Equivalent on 1977-09-30. Applicant: United States Surgical, A Division of Tyco Healthc.
Clearance details
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Product code
- Code GDO
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code GDO
product code GDO- Death
- 5
- Malfunction
- 2,124
- Total
- 2,129
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.