Identity
- Trade Name
- FLEX FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- Flex TO Instrument Support & Assembly FDA UDI
- Model / Reference
- 23498 FDA UDI
- Description
- Flex TO Instrument Support & Assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850190004087 FDA UDI
- 510(k) Number
- K150776 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 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
Moist Heat or Steam Sterilization FDA UDI
Category: Robotic surgical arm system
Flex by Medrobotics Corporation — 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
- Adapter, Bipolar Large Grasping Forceps, Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class I
- Senhance — Asensus Surgical, Inc. · Class II
- ARTAS System — Venus Concept Inc. · Class II
- daVinci Si — Intuitive Surgical, Inc. · Class II
- Adapter, Passive Allis Grasper, Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class I
- NOVADAQ 10 mm Endoscope Adapter — Asensus Surgical Italia S.r.l. · Class I
Cleared under the same submission
K150776 also covers:
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
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
- Medrobotics Corporation
Sources (1)
- FDA UDI 1fadca19-5904-44fb-aa02-0be6f5047f29 34 fields · synced May 30, 2026