Op.n Core ethernet cable I01016

• FDA 510(k) K242914 decided 7 Mar 2025 Active
• FDA GUDID UDI-DI 03701311501459 listed 4 Nov 2025 Listed

1. 7 Mar 2025 Cleared FDA 510(k) K242914
2. 4 Nov 2025 Listed FDA GUDID 03701311501459

Trade name

Op.n Core ethernet cable

Generic name

Electrical-only medical device connection cable, reusable

Model / reference

I01016

Primary DI / UDI-DI

03701311501459

510(k) Number

K242914 ↗

FDA product code

OLO

GMDN term

Electrical-only medical device connection cable, reusable

Device class

Class II

Regulation number

882.4560

GUDID distribution status

In Commercial Distribution

Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).

• Stealth AXiS EM Emitter Arm Bed Kit SS 9736698 by Medtronic Navigation Inc.
• RIO 111613 by MAKO Surgical Corp.
• OMNIBotics NS-5016L by OMNIlife science, Inc.
• REAL INTELLIGENCE™ CORI™ by Blue Belt Technologies, Inc.
• Mako Total Hip Application, Mako Total Knee Application by MAKO Surgical Corp.
• OMNIBotics NV-CRD05 by OMNIlife science, Inc.
• Medtronic 9735283 by Medtronic Navigation Inc.
• Mazor X Spine Disposable Kit KIT0574-12 by MAZOR ROBOTICS LTD
• GX Navigation Instrument System by Life Spine, Inc.
• ROSA Partial Knee System by Orthosoft Inc. (d/b/a) Zimmer CAS

• Op.n Cobot Tool Holder A60000

  Class II

  FDA 510(k) K261113 Active Cleared 22 Jul 2026 GUDID on market

• Op.n™ CoBot Tool Holder Tracker A60001

  Class II

  FDA 510(k) K261113 Active Cleared 22 Jul 2026 GUDID on market

• Op.n™ CoBot Drill Guide Sleeve A60003

  Class II

  FDA 510(k) K261113 Active Cleared 22 Jul 2026 GUDID on market

• Op.n™ CoBot Drill Bit - Ø3mm A60004

  Class II

  FDA 510(k) K261113 Active Cleared 22 Jul 2026 GUDID on market

See all devices from Ecential Robotics →