# Creo Medical, Ltd.

- Location (FDA's records): Chepstow, GB
- FDA decisions: 10 (2017–2025): 10 510(k) clearances
- Product codes: KNS (5), NEY (4), GEI (1)
- 510(k) review time since 2016: median 258 days, against 163 for FDA's reviews in the same codes and years (3 of 10 faster)
- Predicates its devices cite: 14 (7 its own); citations of its devices by later devices: 7 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Erbe USA, Inc.: 2 (https://510kreport.com/company/erbe-usa)
- Covidien: 2 (https://510kreport.com/company/covidien)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)

## Its most-cited devices
- K230328: Speedboat Flush SB1 Instrument (2023), cited by 3
- K171983: Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory (2017), cited by 1
- K200003: NP1 Instrument, Creo Electrosurgical System (2020), cited by 1
- K223138: AB1 Electrosurgical Instrument, Creo Electrosurgical System (2023), cited by 1
- K200298: ABI Instrument, Creo Electrosurgical System (2021), cited by 1

## Recent decisions
- K242774: SpydrBlade Flex Instrument (PRD-RG1-001) (Jun 6, 2025)
- K242983: CROMA Electrosurgical Generator (PRD-EMR-050) (Feb 5, 2025)
- K242061: Reusable Interface Cable 1.5 m (PRD-IFC-002) (Aug 15, 2024)
- K230328: Speedboat Flush SB1 Instrument (Oct 31, 2023)
- K223138: AB1 Electrosurgical Instrument, Creo Electrosurgical System (Jun 26, 2023)
- K221672: Creo Electrosurgical System with NP1 Instrument (Feb 14, 2023)
- K200298: ABI Instrument, Creo Electrosurgical System (Jan 5, 2021)
- K200003: NP1 Instrument, Creo Electrosurgical System (Oct 28, 2020)

Source page: https://510kreport.com/company/creo-medical