Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar— 510(k) K223593
Substantially EquivalentTaiwan Surgical Corporation
FDA 510(k) clearance K223593 for Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar, Substantially Equivalent on 2023-03-22. Applicant: Taiwan Surgical Corporation. Device class: 2.
Clearance details
- Applicant
- Taiwan Surgical Corporation
- 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
- Zhubei City, TW
Recent devices under product code GCJ
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- 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)
More clearances from Taiwan Surgical Corporation
view allAdverse 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.