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.. Device class: 2.
Clearance details
- Applicant
- Jiangsu Channel Medical Device Co., Ltd.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kushan, CN
Recent devices under product code GCJ
view all- K262397 — CuratOR EX2742
- K260884 — UNIDRIVE Select System
- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
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.