FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000
K Number: K880166
·
Decision Feb 18, 1988
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
12
Review Days
35
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Basic Information
- Device Name
- BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000
- K Number
- K880166
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Clinical Technology Corp.
- Date Received
- January 14, 1988
- Decision Date
- February 18, 1988
- Product Code
- LFL
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
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Tenex 2nd Generation System
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CUSA® Clarity Ultrasonic Surgical Aspirator System
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Ultrasonic Surgical System
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Clinical Technology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K925080 | TEK-LUBE | Jan 31, 1994 | Substantially Equivalent |
| K872867 | BIOSIGN | Jul 6, 1988 | Substantially Equivalent |
| K872705 | BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT) | Sep 1, 1987 | Substantially Equivalent |
| K855138 | BOVIE ULTRASONIC SURGICAL SYSTEM | Nov 10, 1986 | Substantially Equivalent |
| K854231 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES | May 2, 1986 | Substantially Equivalent |
| K853507 | STERI-GRIP | Sep 5, 1985 | Substantially Equivalent |
| K852986 | GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN | Aug 19, 1985 | Substantially Equivalent |
| K844565 | BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT) | Feb 21, 1985 | Substantially Equivalent |
| K841272 | SICKLE-STAT HEMOGLOBIN S SCREEN KIT | Apr 13, 1984 | Substantially Equivalent |
| K823077 | URINARY BLADDER TEMP. SENSOR #81-003 | Mar 9, 1983 | Substantially Equivalent |