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SpydrBlade Flex
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref PRD-RG1-001510(k) K242774
by Creo Medical
Identity
- Trade Name
- SpydrBlade Flex EUDAMED
- Device Name
- SpydrBlade Flex RG1 Instrument EUDAMED
- Model / Reference
- PRD-RG1-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060359560414 EUDAMED
- Basic UDI-DI
- 506035956SPYDERBLADERG149 EUDAMED
- 510(k) Number
- K242774 FDA 510(k)
- FDA Product Code
- KNS FDA 510(k)
- EMDN Code
- K0299 ELECTROSURGERY DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4300 FDA 510(k)
- Regulation Number
- 876.4300 FDA 510(k)
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
EUDAMED
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
Category: Percutaneous radio-frequency ablation system generator
SpydrBlade Flex by Creo Medical — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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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 | K242774 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 506035956SPYDERBLADERG149 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Creo Medical
- EUDAMED SRN
- GB-MF-000019076
- Authorised Representative
- Creo Medical, S.L.U. ES-AR-000001355
Sources (2)
- EUDAMED e0a24d03-c870-4d39-875e-bb76a2914491 61 fields · synced Jul 19, 2026
- FDA 510(k) K242774 24 fields · synced May 18, 2026