O.R. CONCEPTS' ELECTROSURGICAL PROBE
FDA 510(k) clearance K923416 · decided 1992-11-20
Clearance details
- K-number
- K923416
- Device name
- O.R. CONCEPTS' ELECTROSURGICAL PROBE
- Applicant
- O.R. Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-10
- Decision date
- 1992-11-20
- Days to decision
- 133 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
- Roanoke, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.