FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE
K Number: K862989
·
Decision Aug 21, 1986
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
25
Applicant Total
2
Review Days
13
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE
- K Number
- K862989
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4360
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Entronics
- Date Received
- August 8, 1986
- Decision Date
- August 21, 1986
- Product Code
- HBC
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HBC | Motor, Drill, Electric | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HBC), ordered by most recent decision date.
Traus SSG10 Surgical System
FDA 510(k)
FDA Class 2
·Neurology
Traus SSG30 Surgical System
FDA 510(k)
FDA Class 2
·Neurology
ORiGO System
FDA 510(k)
FDA Class 2
·Neurology
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
FDA 510(k)
FDA Class 2
·Neurology
hekaDrill
FDA 510(k)
FDA Class 2
·Neurology
MR8 Drill System, Midas Rex MR8 ClearView Tools
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Entronics
| K Number | Device Name | ||
|---|---|---|---|
| K831946 | SURGICAL DRILL-ELECTRIC-HANDPIECE | Nov 3, 1983 | Substantially Equivalent |