FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
DISSECTRON PORTABLE UNIT
K Number: K972612
·
Decision Oct 8, 1997
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
6
Applicant Total
24
Review Days
86
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Basic Information
- Device Name
- DISSECTRON PORTABLE UNIT
- K Number
- K972612
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Satelec
- Date Received
- July 14, 1997
- Decision Date
- October 8, 1997
- Product Code
- LBK
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| LBK | Neurosurgical Ultrasonic Instruments | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LBK), ordered by most recent decision date.
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CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR
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CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.
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AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT
FDA 510(k)
FDA Unclassified
·Unknown
BOVIE ULTRASONIC SURGICAL SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
COOPER LASER SONICS CUSA MODEL 200
FDA 510(k)
FDA Unclassified
·Unknown
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| K082116 | HEMOSTASYL PASTE | Dec 17, 2008 | Substantially Equivalent |
| K072181 | MINI LED AUTOFOCUS | Sep 19, 2007 | Substantially Equivalent |
| K071965 | I-SURGE | Sep 10, 2007 | Substantially Equivalent |
| K060275 | PIEZOTOME | May 3, 2006 | Substantially Equivalent |
| K060274 | PIEZOTOME | May 1, 2006 | Substantially Equivalent |
| K053328 | BIOSPLINT SPLINTING RIBBON | Jan 25, 2006 | Substantially Equivalent |