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Dexter
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 520Model Dexter L6Ref n/aRef 105Ref 516Ref 518510(k) K250435
Identity
- Trade Name
- Dexter EUDAMED
- Device Name
- Monopolar Hook EUDAMEDDexter L6 System EUDAMEDDexter L6 Robot EUDAMEDNeedle Holder EUDAMEDMonopolar Scissors EUDAMED
- Model / Reference
- Dexter L6 EUDAMED520 EUDAMEDn/a EUDAMED105 EUDAMED516 EUDAMED518 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640184840622 EUDAMED07640184840271 EUDAMED07640184840684 EUDAMED07640184840561 EUDAMED07640184840608 EUDAMED
- Basic UDI-DI
- 764018484IN-M1029T EUDAMED764018484SYS-DM-L6-001ND EUDAMED764018484DM-L6001ED EUDAMED764018484IN-N102A2 EUDAMED764018484IN-M1019R EUDAMED
- Direct Marketing DI
- 07640184840684 EUDAMED
- 510(k) Number
- K250435 FDA 510(k)
- FDA Product Code
- SDD FDA 510(k)
- EMDN Code
- K01020299 ROBOTIC SURGERY INSTRUMENT, SINGLE-USE - OTHER EUDAMEDZ12020101 ROBOT-ASSISTED ENDOSCOPIC SURGERY SYSTEMS EUDAMEDK01020203 ROBOTIC SURGERY SCISSORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4965 FDA 510(k)
- Regulation Number
- 878.4965 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- Medical Purpose
- The Distalmotion Dexter L6 System is intended to assist in the accurate control of endoscopes as well as Distalmotion endoscopic instruments including endoscopic dissectors, scissors, forceps / pickups, needle holders, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, electrocautery, suturing, and accessories, during laparoscopic surgical procedures. EUDAMED
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Dexter by Distalmotion SA — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250435 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 764018484IN-M1029T | Class IIb | Active |
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Manufacturer
- Manufacturer
- Distalmotion SA
- EUDAMED SRN
- CH-MF-000037226
- Authorised Representative
- Distalmotion Deutschland GmbH DE-AR-000046740
Sources (6)
- EUDAMED b6cb624c-d8ab-4276-bc76-ce132a468ebb 61 fields · synced Aug 3, 2026
- EUDAMED 75247e30-74b2-498d-90a2-adf9fc873fd6 61 fields · synced May 16, 2026
- EUDAMED 77f8f103-db0e-41a4-ab08-64d9d9ebf1d1 61 fields · synced May 18, 2026
- EUDAMED 84972dd1-d785-4d66-b077-020a6188cacc 61 fields · synced May 18, 2026
- EUDAMED 49ab2c4a-bffe-4be0-9637-363f14be28a2 61 fields · synced May 18, 2026
- FDA 510(k) K250435 24 fields · synced May 18, 2026