FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MISONIX IRRIGATION SYSTEM MOEDL BC20P
K Number: K013417
·
Decision Jan 10, 2002
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
76
Applicant Total
17
Review Days
87
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Basic Information
- Device Name
- MISONIX IRRIGATION SYSTEM MOEDL BC20P
- K Number
- K013417
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Misonix, Inc.
- Date Received
- October 15, 2001
- Decision Date
- January 10, 2002
- Product Code
- GBX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GBX | Catheter, Irrigation | FDA class 1 | General, Plastic Surgery |
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| K123980 | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES | Mar 5, 2013 | Substantially Equivalent |
| K112782 | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES | Dec 1, 2011 | Substantially Equivalent |
| K070779 | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM | Jul 9, 2008 | Substantially Equivalent |
| K070313 | MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | May 11, 2007 | Substantially Equivalent |
| K062471 | ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF | Oct 26, 2006 | Substantially Equivalent |
| K042096 | MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM | Jan 26, 2006 | Substantially Equivalent |
| K052702 | MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY | Nov 21, 2005 | Substantially Equivalent |