Companies / Ronin Surgical

Medical device company profile

Ronin Surgical

Developer and commercializer of branded battery-operated surgical headlight systems.

ManufacturerGeneral Medical & Patient CareHospital Equipment & Consumables

Headquarters🇺🇸United States

FoundedNot confirmed

Commercial statusCommercially availableDocumented marketed products; availability varies by product and country.

EmployeesNot confirmed

Estimated revenueNot confirmed

Official websitewww.roninsurgical.com ↗

Company overview

Ronin Surgical Corp. develops and commercializes Ronin-branded surgical headlight systems. Its current X7 system provides wearable battery-powered illumination during surgical procedures.

The company sells packages with adjustable headbands, batteries, charging equipment and carrying cases. FDA device identification records name Ronin Surgical Corp. as labeler of the X7 and earlier X6 models. The precise physical-production and contract-manufacturing arrangements have not been independently established.

This profile focuses on the current X7 surgical-headlight family. Earlier X6 devices are retained as regulatory and safety context. The official website lists an Austin, Texas remittance address; this does not independently establish an operational headquarters.

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Products & regulatory status How does MedTechIndex get this information?

Summary

Device records identify Ronin Surgical Corp. as labeler of the X7, report commercial distribution and premarket exemption, and assign product code HPP. FDA classifies HPP under 21 CFR 886.4335 as Class I and 510(k)-exempt, subject to exemption limitations. Device listing and exemption are not FDA clearance or approval. ^[2][6]

Device records also identify an earlier X6 model in commercial distribution. That database status does not establish continued availability of new X6 units from the current manufacturer catalog. ^[1]

FDA MAUDE contains X6 reports received in 2023 and 2025 describing patient burns during procedures. The 2023 voluntary report and manufacturer report describe the same event and should not be counted as separate incidents. The manufacturer reported its returned-device testing found performance within specification and disputed device causation. MAUDE reports do not independently establish causation, incidence, a defect or a recall, and these X6 reports are not attributed to the X7. ^[3][4][5]