Data / Medical devices / United Kingdom / Creo Medical Ltd
Creo Medical Ltd: FDA-registered device maker in CHEPSTOW Monmouthshire, United Kingdom, 6 510(k) clearances
Creo Medical Ltd is registered with the FDA (registration 3014925413) in CHEPSTOW Monmouthshire, United Kingdom. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 6, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014925413
- Address
- Unit 2, Beaufort Park Beaufort Park Road, CHEPSTOW Monmouthshire, United Kingdom, NP16 5UH
- Owner or operator
- Creo Medical Ltd (10058797)
- Roles
- Specification developer
- First device listed
- October 29, 2018
- Registered through
- 2026
- Brand names listed
- CROMA Electrosurgical Generator, CROMA Electrosurgical System, Creo Electrosurgical System with NP1 Instrument, Footswitch (7-PG1-132), Reusable Interface Cable 1.5 m (PRD-IFC-002), Speedboat, Speedboat Notch, Speedboat® UltraSlim and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Specification developer | accessdata.fda.gov |
| System, Ablation, Microwave And Accessories | NEY | 2 | Specification developer | accessdata.fda.gov |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 6, 2025 | K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | KNS | Substantially Equivalent | Creo Medical, Ltd. | accessdata.fda.gov |
| February 5, 2025 | K242983 | CROMA Electrosurgical Generator (PRD-EMR-050) | GEI | Substantially Equivalent | Creo Medical, Ltd. | accessdata.fda.gov |
| August 15, 2024 | K242061 | Reusable Interface Cable 1.5 m (PRD-IFC-002) | KNS | Substantially Equivalent | Creo Medical, Ltd. | accessdata.fda.gov |
| October 31, 2023 | K230328 | Speedboat Flush SB1 Instrument | KNS | Substantially Equivalent | Creo Medical, Ltd. | accessdata.fda.gov |
| February 14, 2023 | K221672 | Creo Electrosurgical System with NP1 Instrument | NEY | Substantially Equivalent | Creo Medical, Ltd. | accessdata.fda.gov |
| August 17, 2017 | K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory | KNS | Substantially Equivalent | Creo Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of System, Ablation, Microwave And Accessories
Updated June 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.