K254056
- 510(k) number
- K254056
- Device name
- THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)
- Applicant
- Olympus Medical Systems Corp. JP
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-07-01
- Date received
- 2025-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K254056.pdf
Official FDA record: K254056
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.