REPROCESSED ELECTROSURGICAL INSTRUMENT
FDA 510(k) clearance K110189 · decided 2011-07-18
Clearance details
- K-number
- K110189
- Device name
- REPROCESSED ELECTROSURGICAL INSTRUMENT
- Applicant
- Ascent Healthcare Solutions
- Decision
- Substantially Equivalent
- Date received
- 2011-01-24
- Decision date
- 2011-07-18
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- NUJ
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.