FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240
K Number: K102275
·
Decision Mar 25, 2011
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
5
Review Days
226
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Basic Information
- Device Name
- THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240
- K Number
- K102275
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thermedx, LLC
- Date Received
- August 11, 2010
- Decision Date
- March 25, 2011
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Thermedx, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K210628 | X-FLO Fluid Management System | Nov 4, 2021 | Substantially Equivalent |
| K172048 | FluidSmart | Sep 5, 2017 | Substantially Equivalent |
| K133799 | THERMEDX FLUID MANAGMENT SYSTEM | Jun 20, 2014 | Substantially Equivalent |
| K091939 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 | Jul 23, 2010 | Substantially Equivalent |