VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP— 510(k) K100548
Substantially EquivalentCovidien Lp, Formerly Registered AS Tyco Healthcar
FDA 510(k) clearance K100548 for VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP, Substantially Equivalent on 2010-04-26. 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.