K233958
- 510(k) number
- K233958
- Device name
- hekaDrill
- Applicant
- Zethon, Ltd. GB
- Product code
- ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Includi
- Decision date
- 2024-03-14
- Date received
- 2023-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233958.pdf
Official FDA record: K233958
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.