FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APEX UNIVERSAL DRIVE SYSTEM
K Number: K964548
·
Decision Jan 17, 1997
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
90
Applicant Total
93
Review Days
65
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Basic Information
- Device Name
- APEX UNIVERSAL DRIVE SYSTEM
- K Number
- K964548
- 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
- Linvatec Corp.
- Date Received
- November 13, 1996
- Decision Date
- January 17, 1997
- 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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|---|---|---|---|
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| K083281 | EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- | Feb 25, 2009 | Substantially Equivalent |
| K060198 | MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW | May 11, 2006 | Substantially Equivalent |
| K060260 | MICROPOWER HAND PIECE HIGH SPEED DRILL | Apr 10, 2006 | Substantially Equivalent |
| K060270 | MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL | Apr 10, 2006 | Substantially Equivalent |
| K050519 | ADVANCED TURBO DRIVE SYSTEM | May 17, 2005 | Substantially Equivalent |
| K050497 | BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET | Mar 25, 2005 | Substantially Equivalent |