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Real Intelligence ROB100021F

by Smith & Nephew, Inc.

Real Intelligence ROB100021F 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 30 Jul 2026 (UDI-DI 00885556925171), 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 Number00885556925171 UDI-DI Date30 Jul 2026ListedStatusListed 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 00885556925171 listed 30 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K193120
  2. Listed FDA GUDID 00885556925171

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  • Withdrawn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
Robotic surgical telemanipulation system
Model / Ref / Catalog
ROB100021F
Primary DI / UDI-DI
00885556925171
510(k) Number
FDA product code
OLO
GMDN term
Robotic surgical telemanipulation system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

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)