510(k) K233958
K233958 is an FDA 510(k) premarket notification submitted by Zethon, Ltd. for the device "hekaDrill". The FDA issued a decision of Substantially Equivalent on March 14, 2024. The device falls under product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece), a Class II device regulated under 21 CFR 874.4250. Zethon, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2024
- Date Received
- December 15, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device Class
- Class II
- Regulation Number
- 874.4250
- Review Panel
- EN
- Submission Type