FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SORING GMBH SONOCA 180/190
K Number: K012753
·
Decision Nov 13, 2001
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
7
Review Days
89
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Basic Information
- Device Name
- SORING GMBH SONOCA 180/190
- K Number
- K012753
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Soring GmbH Medizintechnik
- Date Received
- August 16, 2001
- Decision Date
- November 13, 2001
- 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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CUSA® Clarity Ultrasonic Surgical Aspirator System
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Other Clearances by Soring GmbH Medizintechnik
| K Number | Device Name | ||
|---|---|---|---|
| K093511 | SORING MBC200/BCC140 | Apr 16, 2010 | Substantially Equivalent |
| K052183 | SORING GMBH SONOCA LIPO | Oct 7, 2005 | Substantially Equivalent |
| K030028 | CPC BY SORING GMBH | Jan 17, 2003 | Substantially Equivalent |
| K024059 | MBC SERIES | Jan 8, 2003 | Substantially Equivalent |
| K993265 | SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 | Oct 22, 1999 | Substantially Equivalent |
| K992026 | SORING GMBH, SONOCA 300 | Sep 23, 1999 | Substantially Equivalent |