Class Class II

Bladeless Trocar; Bladed Trocar; Hasson Trocar (K241052)

K241052 2024-10-04 Traditional
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Description

Bladeless Trocar; Bladed Trocar; Hasson Trocar by Advamedix, GmbH, an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241052
Clearance Date2024-10-04
Clearance TypeTraditional
Product CodeGCJ
Regulation Number876.1500

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Predicate lineage for K241052

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; Bladed Trocar; Hasson Trocar (K241052) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K141594Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Tr...Unimicro Medical Systems (Shenzhen)...2015

Trace the full predicate network for K241052

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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