Class Class II

HyperSnap Surgical System (HSS) (K250268)

K250268 2025-06-24 Traditional
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Description

HyperSnap Surgical System (HSS) by Hypervision Surgical, an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250268
Clearance Date2025-06-24
Clearance TypeTraditional
Product CodeSFE
Regulation Number876.1500

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Predicate lineage for K250268

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. HyperSnap Surgical System (HSS) (K250268) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K203717Processor VP-7000, Light Source BL-7000X, Image Processing ...Fujifilm Corporaton2021
K112826NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITORMoor Instruments, Ltd.2012

Trace the full predicate network for K250268

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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