FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
hekaDrill
K Number: K233958
·
Decision Mar 14, 2024
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
90
Applicant Total
2
Review Days
90
Basic Information
- Device Name
- hekaDrill
- K Number
- K233958
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4250
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zethon Ltd
- Date Received
- December 15, 2023
- Decision Date
- March 14, 2024
- Product Code
- ERL
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Zethon Ltd
| K Number | Device Name | ||
|---|---|---|---|
| K193630 | hekaDrill | Apr 9, 2021 | Substantially Equivalent |