FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONICISION STERILIZATION TRAY
K Number: K131170
·
Decision Aug 28, 2013
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
279
Applicant Total
6
Review Days
126
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Basic Information
- Device Name
- SONICISION STERILIZATION TRAY
- K Number
- K131170
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Covidien, Formerly Valleylab, A Division of Tyco H
- Date Received
- April 24, 2013
- Decision Date
- August 28, 2013
- Product Code
- KCT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | FDA class 2 | General Hospital |
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Other Clearances by Covidien, Formerly Valleylab, A Division of Tyco H
| K Number | Device Name | ||
|---|---|---|---|
| K141371 | SONICISION CORDLESS ULTRASONIC DISSECTOR | Aug 7, 2014 | Substantially Equivalent |
| K133338 | LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) | Dec 20, 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 |