Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bladeless Trocar – Artemis Lap Cannula

K-Number: K231400 · 2023-08-04

ApplicantT.A.G. Medical Products Corporation, Ltd.
Decision Date2023-08-04
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Bladeless Trocar – Artemis Lap Cannula is a medical device manufactured by T.A.G. Medical Products Corporation, Ltd.. It received FDA 510(k) clearance on 2023-08-04 under approval number K231400. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bladeless Trocar – Artemis Lap Cannula?

Bladeless Trocar – Artemis Lap Cannula is a medical device that received FDA 510(k) clearance on 2023-08-04. It is manufactured by T.A.G. Medical Products Corporation, Ltd.. The 510(k) number is K231400.

When was Bladeless Trocar – Artemis Lap Cannula approved by the FDA?

Bladeless Trocar – Artemis Lap Cannula received FDA 510(k) clearance on 2023-08-04, under approval number K231400.

What company makes Bladeless Trocar – Artemis Lap Cannula?

Bladeless Trocar – Artemis Lap Cannula is manufactured by T.A.G. Medical Products Corporation, Ltd..

What is the FDA product code for Bladeless Trocar – Artemis Lap Cannula?

The FDA product code for Bladeless Trocar – Artemis Lap Cannula is GCJ.

Other Devices by T.A.G. Medical Products Corporation, Ltd.

K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire K202178VersaLoop Anchor System K210498Betta Link Knotless Implant System K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire K230058Bladeless Trocar – Artemis Lap Cannula

Related Devices (Code: GCJ)

K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien K160801Well Lead Extraction BagWell Lead Medical Co., Ltd. K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp. K161720Standard ClampStandard Bariatrics K162445LiVac Retractor SystemLivac Pty, Ltd. K162584VersaOne Bladeless TrocarCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑