Identity
- Trade Name
- REAL INTELLIGENCE FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- REAL INTELLIGENCE FOOT PEDAL FDA UDI
- Model / Reference
- ROB10026 FDA UDI
- Description
- REAL INTELLIGENCE FOOT PEDAL FDA UDI
Identifiers
- Catalog Number
- ROB10026 FDA UDI
- Primary DI / UDI-DI
- 00885556757444 FDA UDI
- 510(k) Number
- K193120 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
No
FDA UDI
Category: Robotic surgical arm system
Real Intelligence by Smith & Nephew, Inc. — 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
K193120 also covers:
- CORI — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
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 |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 268cbeae-cdbf-4cbd-82a7-f1b8d5f04c3d 36 fields · synced Jun 8, 2026