# Ecential Robotics

- Location (FDA's records): Gieres, FR
- FDA decisions: 7 (2022–2026): 7 510(k) clearances
- Product codes: OLO (5), OWB (2)
- 510(k) review time since 2016: median 90 days, against 90 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 13 (7 its own); citations of its devices by later devices: 9 (7 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Surgivisio: 3 (https://510kreport.com/company/surgivisio)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Stryker Corporate: 1 (https://510kreport.com/company/stryker-corporate)
- Medtech S.A: 1 (https://510kreport.com/company/medtech-s-a)

## Firms that cite its devices most
- Spineart: 2 (https://510kreport.com/company/spineart)

## Its most-cited devices
- K220627: SURGIVISIO Device (2022), cited by 2
- K231886: SURGIVISIO Device (2023), cited by 2
- K242914: Op.n (TM) Navigation (2025), cited by 1
- K220946: SURGIVISIO Device (2022), cited by 1
- K233228: Spine Navigation and Robotic-Assistance Device (2024), cited by 1
- K221028: SURGIVISIO Device (2022), cited by 1

## Recent decisions
- K261113: Op.n™ Spine Navigation and Robotic Guidance (Jul 22, 2026)
- K242914: Op.n (TM) Navigation (Mar 7, 2025)
- K233228: Spine Navigation and Robotic-Assistance Device (Jun 14, 2024)
- K231886: SURGIVISIO Device (Jul 27, 2023)
- K221028: SURGIVISIO Device (Jul 6, 2022)
- K220946: SURGIVISIO Device (Apr 15, 2022)
- K220627: SURGIVISIO Device (Mar 18, 2022)

Source page: https://510kreport.com/company/ecential-robotics