Skip to content

Op.n™ Core Station I01020

by Ecential Robotics

Op.n™ Core Station I01020 is a Class II device made by Ecential Robotics, cleared under FDA 510(k) K261113 on 22 Jul 2026 and listed in FDA GUDID since 13 Sep 2026 (UDI-DI 03701311501671), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K261113

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03701311501671 UDI-DI Date13 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK261113 Date22 Jul 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K261113 decided 22 Jul 2026 Active
  • FDA GUDID UDI-DI 03701311501671 listed 13 Sep 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K261113
  2. Listed FDA GUDID 03701311501671

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Op.n™ Core Station
Generic name
Optical surgical navigation/tracking system workstation, mobile
Model / reference
I01020
Primary DI / UDI-DI
03701311501671
510(k) Number
FDA product code
OLO
GMDN term
Optical surgical navigation/tracking system workstation, mobile
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K261113)

and 8 more cleared under K261113

Similar devices

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

Other devices from Ecential Robotics

See all devices from Ecential Robotics →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)