FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SONICISION CORDLESS ULTRASONIC DISSECTOR
K Number: K141371
·
Decision Aug 7, 2014
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
6
Review Days
72
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Basic Information
- Device Name
- SONICISION CORDLESS ULTRASONIC DISSECTOR
- K Number
- K141371
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Covidien, Formerly Valleylab, A Division of Tyco H
- Date Received
- May 27, 2014
- Decision Date
- August 7, 2014
- 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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Other Clearances by Covidien, Formerly Valleylab, A Division of Tyco H
| K Number | Device Name | ||
|---|---|---|---|
| K133338 | LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) | Dec 20, 2013 | Substantially Equivalent |
| K131170 | SONICISION STERILIZATION TRAY | Aug 28, 2013 | Substantially Equivalent |
| K123444 | LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER | Jan 30, 2013 | Substantially Equivalent |
| K113572 | LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER | Sep 5, 2012 | Substantially Equivalent |
| K102913 | FORCETRIAD | May 6, 2011 | Substantially Equivalent |