Bladeless Trocar Artemis Lap Cannula— 510(k) K231400
Substantially EquivalentT.A.G. Medical Products Corporation, Ltd.
FDA 510(k) clearance K231400 for Bladeless Trocar Artemis Lap Cannula, Substantially Equivalent on 2023-08-04. Applicant: T.A.G. Medical Products Corporation, Ltd.. Device class: 2.
Clearance details
- Applicant
- T.A.G. Medical Products Corporation, 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
- Special
- Location
- Gaaton, IL
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- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
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- 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 T.A.G. Medical Products Corporation, Ltd.
view all- K253858 — GFS - Sterile Screws and Top Hat
- K230058 — Bladeless Trocar Artemis Lap Cannula
- K221731 — FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
- K210498 — Betta Link Knotless Implant System
- K202178 — VersaLoop Anchor System
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.