Identity
- Trade Name
- CoBot FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Model / Reference
- I00019 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701311500322 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Robotic surgical arm system
CoBot by Ecential Robotics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical arm system.
- daVinci Xi — Intuitive Surgical, Inc. · Class II
- SHURUI Large Tissue Forceps — Beijing Surgerii Robotics Company Limited · Class IIb
- FLEX — Medrobotics Corporation · Class II
- Flex — Medrobotics Corporation · Class II
- Adapter, Bipolar Large Grasping Forceps, Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class I
- FLEX — Medrobotics Corporation · Class II
- Senhance — Asensus Surgical, Inc. · Class II
- ARTAS System — Venus Concept Inc. · Class II
Cleared under the same submission
K221028 also covers:
- 3.5 mm Hex Head Screwdriver — ECENTIAL ROBOTICS
- 3DSRW Software — ECENTIAL ROBOTICS
- CoBot, Drill Bit — ECENTIAL ROBOTICS
- CoBot, Drill Guide – Cortical tip — ECENTIAL ROBOTICS
- CoBot, Drill Guide – Sleeve — ECENTIAL ROBOTICS
- CoBot, Spine Instruments tray — ECENTIAL ROBOTICS
- CoBot, Tool Holder — ECENTIAL ROBOTICS
- Fixation screw — ECENTIAL ROBOTICS
- Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125mm — ECENTIAL ROBOTICS
- Navigated Targeting Needle SPX1, Trocar tip – 11G, 125 mm — ECENTIAL ROBOTICS
- Navigation set SPX1, Targeting Needle SPX1, Bevel Tip - 11G, 125 mm — ECENTIAL ROBOTICS
- Navigation set SPX1, Targeting Needle SPX1, Trocar Tip - 11G, 125 mm — ECENTIAL ROBOTICS
K231886 also covers:
- 3.5 mm Hex Head Screwdriver — ECENTIAL ROBOTICS
- 3DSRW Software — ECENTIAL ROBOTICS
- CoBot, Drill Bit — ECENTIAL ROBOTICS
- CoBot, Drill Guide – Cortical tip — ECENTIAL ROBOTICS
- CoBot, Drill Guide – Sleeve — ECENTIAL ROBOTICS
- CoBot, Spine Instruments tray — ECENTIAL ROBOTICS
- CoBot, Tool Holder — ECENTIAL ROBOTICS
- Fixation screw — ECENTIAL ROBOTICS
- Robotic, Tool Holder – Tracker — ECENTIAL ROBOTICS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ecential Robotics
Sources (1)
- FDA UDI 09c3a433-6bd9-4cdf-953c-aecde97eb75c 34 fields · synced May 29, 2026