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
- Product 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
Recent devices under product code GCJ
view allMore 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.