BIPOLAR ELECTROSURGICAL PROBES & INSTRUMENTS
FDA 510(k) clearance K922523 · decided 1992-09-23
Clearance details
- K-number
- K922523
- Device name
- BIPOLAR ELECTROSURGICAL PROBES & INSTRUMENTS
- Applicant
- Ximed Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1992-05-28
- Decision date
- 1992-09-23
- Days to decision
- 118 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
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.