SILS PORT MODEL SILSPT15— 510(k) K093372
Substantially EquivalentCovidien Lp, Formerly Registered AS Tyco Healthcar
FDA 510(k) clearance K093372 for SILS PORT MODEL SILSPT15, Substantially Equivalent on 2009-12-03. Applicant: Covidien Lp, Formerly Registered AS Tyco Healthcar.
Clearance details
- Applicant
- Covidien Lp, Formerly Registered AS Tyco Healthcar
- Product code
- Code GCJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- North Haven, CT, US
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.