FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EDI-BUR MICRODRILL SYSTEMS
K Number: K945438
·
Decision Nov 22, 1994
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
90
Applicant Total
14
Review Days
33
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
- EDI-BUR MICRODRILL SYSTEMS
- K Number
- K945438
- 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
- Micromed Development Corp.
- Date Received
- October 20, 1994
- Decision Date
- November 22, 1994
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ERL), ordered by most recent decision date.
Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
hekaDrill
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ORiGO System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
AMADEO, M-UK1015 (incl. attachments and accessories)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Celeris, Disposable Sinus Debrider
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Micromed Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K945105 | POLY/PLATINUM WIRE PISTON | May 14, 1996 | Substantially Equivalent |
| K945831 | DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT | Jan 20, 1995 | Substantially Equivalent |
| K945242 | NERVE MONITOR ELECTRODES/STIMULATOR PROBES | Dec 27, 1994 | Substantially Equivalent |
| K945104 | MICROMED PARTIAL REGULAR AND PARTIAL OFFSET | Nov 22, 1994 | Substantially Equivalent |
| K945107 | POLY-WIRE PISTON | Nov 22, 1994 | Substantially Equivalent |
| K945108 | POLY PISTON | Nov 22, 1994 | Substantially Equivalent |
| K945106 | MICROMED TOTAL REGULAR AND PARTIAL OFFSET | Nov 22, 1994 | Substantially Equivalent |
| K943848 | COLLAR BUTTON VENTURI VENT TUBE | Sep 16, 1994 | Substantially Equivalent |
| K943847 | BOBBIN STYLE VENTURI VENT TUBE | Sep 2, 1994 | Substantially Equivalent |
| K943849 | GROMMENT STYLE VENTURI TUBE | Sep 2, 1994 | Substantially Equivalent |