Karl Storz 3D4K 10mm Endoscope Adapter
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Karl Storz 3D4K 10mm 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 3D4K 10mm Endoscope Adapter FDA UDI
- Model / Reference
- Senhance Adapters EUDAMEDX9007775 EUDAMEDFDA UDI
- Description
- Karl Storz 3D4K 10mm Endoscope Adapter FDA UDI
Identifiers
- Catalog Number
- X9007775 FDA UDI
- Primary DI / UDI-DI
- 00815440022280 EUDAMEDFDA UDI
- Basic UDI-DI
- 081544002TD006UP EUDAMED
- Direct Marketing DI
- 00815440022280 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
- Lithuania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Robotic surgical arm system
Karl Storz 3D4K 10mm Endoscope Adapter by Asensus Surgical Italia S.r.l. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Robotic surgical arm system.
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- 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
CE/MDR
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 0e06dffd-289f-421f-bd99-78006c0b159c 61 fields · synced Jul 22, 2026
- FDA UDI a49c8a5c-d3a2-42a5-804e-a8fc35ff71fc 35 fields · synced May 29, 2026