Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)— 510(k) K240196
Substantially EquivalentYuwonmeditech Co., Ltd.
FDA 510(k) clearance K240196 for Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12), Substantially Equivalent on 2024-06-18. Applicant: Yuwonmeditech Co., Ltd..
Clearance details
- Applicant
- Yuwonmeditech Co., Ltd.
- Product code
- Code GCJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wonju-Si, KR
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.