Class Class II

Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) (K230480)

K230480 2023-04-28 Special
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Description

Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) by Teleflex Medical, an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK230480
Clearance Date2023-04-28
Clearance TypeSpecial
Product CodeFZP
Regulation Number878.4300

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Predicate lineage for K230480

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. Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) (K230480) cites 2 predicate devices and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K152081Weck Auto Endo5 Hem-o-lok Ligating Clip ApplierTeleflexmedical, Inc.2015
K133202HEM-O-LOK LIGATING CLIPTeleflex Medical2013

Later devices that cite this one as their predicate

Devices that cite K230480
K numberDeviceApplicantYear
K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and In...Taiwan Surgical Corporation2026

Trace the full predicate network for K230480

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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