FDA 510(k)

HyperSnap Surgical System (HSS)

K-Number: K250268 · 2025-06-24

Decision Date2025-06-24

Product CodeSFE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

HyperSnap Surgical System (HSS) is the device name listed in this FDA 510(k) record. The listed applicant is Hypervision Surgical. It received FDA 510(k) clearance on 2025-06-24 under 510(k) number K250268. The device is classified under product code SFE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HyperSnap Surgical System (HSS)?

HyperSnap Surgical System (HSS) is a medical device that received FDA 510(k) clearance on 2025-06-24. The listed applicant is Hypervision Surgical. The 510(k) number is K250268.

When did HyperSnap Surgical System (HSS) receive FDA 510(k) clearance?

HyperSnap Surgical System (HSS) received FDA 510(k) clearance on 2025-06-24, under 510(k) number K250268.

Who is the listed applicant for HyperSnap Surgical System (HSS)?

The FDA 510(k) record lists Hypervision Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HyperSnap Surgical System (HSS)?

The FDA product code for HyperSnap Surgical System (HSS) is SFE.

Related Devices (Code: SFE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.