FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BOVIE ULTRASONIC SURGICAL ASPIRATOR
K Number: K932094
·
Decision Jul 21, 1993
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
22
Review Days
82
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Basic Information
- Device Name
- BOVIE ULTRASONIC SURGICAL ASPIRATOR
- K Number
- K932094
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mdt Corp., Inc.
- Date Received
- April 30, 1993
- Decision Date
- July 21, 1993
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFL), ordered by most recent decision date.
CUSA® Clarity Ultrasonic Surgical Aspirator System
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SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)
FDA 510(k)
FDA Unclassified
·Unknown
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
FDA 510(k)
FDA Unclassified
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Tenex 2nd Generation System
FDA 510(k)
FDA Unclassified
·Unknown
CUSA® Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
·Unknown
Ultrasonic Surgical System
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Mdt Corp., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960777 | MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR | May 23, 1996 | Substantially Equivalent |
| K942485 | MDT UROLOGY TABLE | Aug 26, 1994 | Substantially Equivalent |
| K942486 | IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE | Aug 10, 1994 | Substantially Equivalent |
| K924380 | MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE | Feb 16, 1994 | Substantially Equivalent |
| K926081 | DENTAL LIGHT | Jan 26, 1994 | Substantially Equivalent |
| K924955 | MDT/HARVEY MC-8 AND MC-10 | Oct 15, 1993 | Substantially Equivalent |
| K931169 | MDT DENTAL CHAIR | May 20, 1993 | Substantially Equivalent |
| K920930 | MDT/CASTLE 10/90 DUAL LOAD STATION | Mar 31, 1993 | Substantially Equivalent |
| K922212 | MDT CASTLE BIOSIGN TEST PACK | Aug 10, 1992 | Substantially Equivalent |
| K914758 | MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE | Dec 19, 1991 | Substantially Equivalent |