FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TORX OR TYPE MICRO MOTOR HANDPIECE
K Number: K822008
·
Decision Aug 12, 1982
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
90
Applicant Total
94
Review Days
35
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Basic Information
- Device Name
- TORX OR TYPE MICRO MOTOR HANDPIECE
- K Number
- K822008
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4250
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Kelleher Corp.
- Date Received
- July 8, 1982
- Decision Date
- August 12, 1982
- 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.
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Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
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Other Clearances by Kelleher Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K822268 | NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH | Jan 28, 1983 | Substantially Equivalent |
| K822618 | EMERGENCY TRACHEOSTOMY INSTRUMENT SET | Jan 28, 1983 | Substantially Equivalent |
| K823083 | ELECTROSURGICAL UNIT | Dec 7, 1982 | Substantially Equivalent |
| K823111 | NYSTYMOGRAPH ACCESS | Nov 22, 1982 | Substantially Equivalent |
| K822252 | ENT TREATMENT UNITS | Nov 22, 1982 | Substantially Equivalent |
| K822272 | HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS | Nov 10, 1982 | Substantially Equivalent |
| K822017 | TYMPANOSTOMY TUBES & VARIOUS TYPES | Oct 27, 1982 | Substantially Equivalent |
| K822257 | VARIOUS TYPES OF LIGHT SOURCE HANDLES | Oct 26, 1982 | Substantially Equivalent |
| K822259 | LARYNGEAL SPATULAS | Oct 22, 1982 | Substantially Equivalent |
| K822004 | FACE SHIELDS | Oct 20, 1982 | Substantially Equivalent |