HyperSnap Surgical System (HSS)
K-Number: K250268 · 2025-06-24
ApplicantHypervision Surgical
Decision Date2025-06-24
Product CodeSFE
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
HyperSnap Surgical System (HSS) is a medical device manufactured by Hypervision Surgical. It received FDA 510(k) clearance on 2025-06-24 under approval 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. It is manufactured by Hypervision Surgical. The 510(k) number is K250268.
When was HyperSnap Surgical System (HSS) approved by the FDA?
HyperSnap Surgical System (HSS) received FDA 510(k) clearance on 2025-06-24, under approval number K250268.
What company makes HyperSnap Surgical System (HSS)?
HyperSnap Surgical System (HSS) is manufactured by Hypervision Surgical.
What is the FDA product code for HyperSnap Surgical System (HSS)?
The FDA product code for HyperSnap Surgical System (HSS) is SFE.
Related Clinical Trials
NCT01143454
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
RECRUITING
NCT06011187
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
COMPLETED
NCT07301385
Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study
ACTIVE_NOT_RECRUITING
NCT07613892
Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives
COMPLETED
NCT05764954
A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma
ACTIVE_NOT_RECRUITING
NCT07489820
Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation
NOT_YET_RECRUITING
Related PubMed Literature
PMID: 42201559
Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system.
Journal of robotic surgery (2026)
PMID: 41160299
Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication.
International journal of clinical oncology (2025)
PMID: 40775988
B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation.
Studies in health technology and informatics (2025)
PMID: 40346298
An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients.
NPJ digital medicine (2025)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.