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KARL STORZ 5 mm Endoscope Adapter
EUDAMEDFDA UDIClass I (EU MDR)
Ref X9007660Model Senhance Adapters
Identity
- Trade Name
- KARL STORZ 5 mm Endoscope Adapter EUDAMEDSenhance FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- Adapter, Allis Grasper Ø 5 mm x 240 mm EUDAMEDKARL STORZ 5 mm Endoscope Adapter FDA UDI
- Model / Reference
- Senhance Adapters EUDAMEDX9007660 EUDAMEDFDA UDI
- Description
- KARL STORZ 5 mm Endoscope Adapter FDA UDI
Identifiers
- Catalog Number
- 500-21016 FDA UDI
- Primary DI / UDI-DI
- 00815440021757 EUDAMEDFDA UDI
- Basic UDI-DI
- 081544002TD006UP EUDAMED
- Direct Marketing DI
- 00815440021757 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
KARL STORZ 5 mm Endoscope Adapter by Asensus Surgical Italia S.r.l. — Class I — MDR, FDA UDI — listed in EUDAMED, 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
- FLEX — Medrobotics Corporation · Class II
- Senhance — Asensus Surgical, Inc. · Class II
- ARTAS System — Venus Concept Inc. · Class II
- daVinci Si — Intuitive Surgical, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081544002TD006UP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Asensus Surgical Italia S.r.l.
- EUDAMED SRN
- IT-MF-000007964
Sources (2)
- EUDAMED 5c91f0d5-5ef5-434f-88c1-4c599df2e8d0 61 fields · synced Jun 18, 2026
- FDA UDI 36ecea22-52ab-4ed0-8947-33fdfd691889 35 fields · synced May 30, 2026