FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
K Number: K200250
·
Decision Jun 26, 2020
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
74
Applicant Total
50
Review Days
144
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Basic Information
- Device Name
- Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
- K Number
- K200250
- 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
- Megadyne Medical Products, Inc.
- Date Received
- February 3, 2020
- Decision Date
- June 26, 2020
- 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 |
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Other Clearances by Megadyne Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233644 | Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) | Jul 12, 2024 | Substantially Equivalent |
| K213696 | ETHICON Megadyne Electrosurgical Generator | Jan 21, 2022 | Substantially Equivalent |
| K193145 | Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch | Mar 24, 2020 | Substantially Equivalent |
| K191328 | Megadyne Foot Switch | Jul 26, 2019 | Substantially Equivalent |
| K141587 | E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER | Feb 18, 2015 | Substantially Equivalent |
| K133726 | MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE | Jan 24, 2014 | Substantially Equivalent |
| K080741 | MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE | Dec 16, 2008 | Substantially Equivalent |
| K081791 | E-Z CLEAN ELECTROSURGICAL ELECTRODE | Oct 21, 2008 | Substantially Equivalent |
| K072559 | SUCTION COAGULATOR | Oct 5, 2007 | Substantially Equivalent |
| K050579 | MEGA POWER ELECTROSURGICAL GENERATOR | Mar 24, 2005 | Substantially Equivalent |