Class Class II

Bladeless Trocar – Artemis Lap Cannula (K230058)

K230058 2023-04-28 Traditional
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Description

Bladeless Trocar – Artemis Lap Cannula by T.A.G. Medical Products Corporation, Ltd., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK230058
Clearance Date2023-04-28
Clearance TypeTraditional
Product CodeGCJ
Regulation Number876.1500

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Predicate lineage for K230058

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Bladeless Trocar – Artemis Lap Cannula (K230058) cites 1 predicate device and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K032676ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOP...Ethicon Endo-Surgery, Inc.2003

Later devices that cite this one as their predicate

Devices that cite K230058
K numberDeviceApplicantYear
K231400Bladeless Trocar – Artemis Lap CannulaT.A.G. Medical Products Corporation...2023

Trace the full predicate network for K230058

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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