Skip to content

Real Intelligence ROB10002

by Smith & Nephew, Inc.

Real Intelligence ROB10002 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K193120 on 14 Feb 2020 and listed in FDA GUDID since 1 May 2020 (UDI-DI 00885556756249), active as of 23 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 23 Oct 2026

Documents

510(k) K193120

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885556756249 UDI-DI Date1 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193120 Date14 Feb 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193120 decided 14 Feb 2020 Active
  • FDA GUDID UDI-DI 00885556756249 listed 1 May 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K193120
  2. Listed FDA GUDID 00885556756249

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Real Intelligence
Generic name
Optical surgical navigation/tracking system workstation, mobile
Model / Ref / Catalog
ROB10002
Primary DI / UDI-DI
00885556756249
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

Category: Optical surgical navigation device tracking system workstation, mobile

Cleared under the same submission (K193120)

and 8 more cleared under K193120

Similar devices

Other devices filed under FDA product code OLO (Orthopedic stereotaxic instrument).

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)