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Senhance
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref X9007015Model Senhance Adapters
Identity
- Trade Name
- Adapter, Mixter Dissector, Long, Ø 5 mm x 410 mm EUDAMEDSenhance FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- Adapter, Allis Grasper Ø 5 mm x 240 mm EUDAMEDAdapter, Mixter Dissector, Long FDA UDI
- Model / Reference
- X9007015 EUDAMEDFDA UDISenhance Adapters EUDAMED
- Description
- Adapter, Mixter Dissector, Long FDA UDI
Identifiers
- Catalog Number
- 200-21060 FDA UDI
- Primary DI / UDI-DI
- 00815440020422 EUDAMEDFDA UDI
- Basic UDI-DI
- 081544002TD006UP EUDAMED
- Direct Marketing DI
- 00815440020422 EUDAMED
- 510(k) Number
- K171120 FDA UDI
- FDA Product Code
- NAY FDA UDI
- EMDN Code
- Z1202018099 REMOTE CONTROL ROBOT-ASSISTED ENDOSCOPIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Moist Heat or Steam Sterilization FDA UDI
Category: Robotic surgical arm system
Senhance by Asensus Surgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- ARTAS System — Venus Concept Inc. · Class II
- daVinci Si — Intuitive Surgical, Inc. · Class II
Cleared under the same submission
K171120 also covers:
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Asensus Surgical, Inc.
Sources (2)
- FDA UDI 676be1ba-e05c-4755-a705-32fda3ef72a2 35 fields · synced Sep 18, 2026
- EUDAMED 3858750c-ab7c-4d98-a1d6-6d3fad4d4cae 61 fields · synced Jun 19, 2026