FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RapidVac Smoke Evacuator System
K Number: K142335
·
Decision Jan 14, 2015
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
74
Applicant Total
130
Review Days
146
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Basic Information
- Device Name
- RapidVac Smoke Evacuator System
- K Number
- K142335
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5070
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Covidien
- Date Received
- August 21, 2014
- Decision Date
- January 14, 2015
- Product Code
- FYD
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FYD), ordered by most recent decision date.
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NEBULAE SRS Laparoscopic Surgical Smoke Removal System
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Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
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