Class Class II

Disposable Endoscopic Cutter Stapler and Cartridge (K211197)

K211197 2023-01-19 Traditional
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Description

Disposable Endoscopic Cutter Stapler and Cartridge by Changzhou Waston Medical Appliance Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK211197
Clearance Date2023-01-19
Clearance TypeTraditional
Product CodeGDW
Regulation Number878.4750

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Predicate lineage for K211197

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. Disposable Endoscopic Cutter Stapler and Cartridge (K211197) 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
K161757Single Use Curved Cutters, Single Use Circular Staplers, Si...Victor Medical Instruments Co., Ltd.2016

Trace the full predicate network for K211197

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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