Home › CREO MEDICAL LIMITED › Speedboat UltraSlim Short
Speedboat UltraSlim Short
CREO MEDICAL LIMITED · Model PRD-SB1-002 · UDI-DI 05060359560674
KNS
Prescription
1
510(k) clearances
17,612
Adverse events (83 deaths)
125
Recalls
117
Facilities
Description
Speedboat is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-19 | Olympus Corporation of the Americas | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| 2026-08-19 | Olympus Corporation of the Americas | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| 2026-08-19 | Olympus Corporation of the Americas | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| 2026-08-19 | Olympus Corporation of the Americas | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.