Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)— 510(k) K232866
Substantially EquivalentJiangsu Channel Medical Device Co., Ltd.
FDA 510(k) clearance K232866 for Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars), Substantially Equivalent on 2023-11-07. Applicant: Jiangsu Channel Medical Device Co., Ltd..
Clearance details
- Applicant
- Jiangsu Channel Medical Device Co., Ltd.
- Product code
- Code GCJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kushan, CN
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.