Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OMNI Surgical System

K-Number: K202678 · 2021-03-01

ApplicantSight Sciences, Inc.
Decision Date2021-03-01
Product CodeMRH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OMNI Surgical System is a medical device manufactured by Sight Sciences, Inc.. It received FDA 510(k) clearance on 2021-03-01 under approval number K202678. The device is classified under product code MRH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI Surgical System?

OMNI Surgical System is a medical device that received FDA 510(k) clearance on 2021-03-01. It is manufactured by Sight Sciences, Inc.. The 510(k) number is K202678.

When was OMNI Surgical System approved by the FDA?

OMNI Surgical System received FDA 510(k) clearance on 2021-03-01, under approval number K202678.

What company makes OMNI Surgical System?

OMNI Surgical System is manufactured by Sight Sciences, Inc..

What is the FDA product code for OMNI Surgical System?

The FDA product code for OMNI Surgical System is MRH.

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: 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)

Other Devices by Sight Sciences, Inc.

K173332OMNI Surgical System K171905VISCO 360 Viscosurgical System K201953OMNI PLUS Surgical System K213045TearCare System K231084TearCare MGX System K232214OMNI Surgical System

View all 9 devices →

Related Devices (Code: MRH)

K173332OMNI Surgical SystemSight Sciences, Inc. K171905VISCO 360 Viscosurgical SystemSight Sciences, Inc. K201953OMNI PLUS Surgical SystemSight Sciences, Inc. K211680Streamline Surgical SystemNew World Medical, Inc. K213173TrabEx ProMicrosurgical Technologies, Inc. K212797iPrime Viscodelivery SystemGlaukos

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.

↑