THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240
FDA 510(k) clearance K102275 · decided 2011-03-25
Clearance details
- K-number
- K102275
- Device name
- THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240
- Applicant
- Thermedx, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-08-11
- Decision date
- 2011-03-25
- Days to decision
- 226 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Solon, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.