AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
FDA 510(k) clearance K021929 · decided 2002-09-10
Clearance details
- K-number
- K021929
- Device name
- AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
- Applicant
- Axya Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-12
- Decision date
- 2002-09-10
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.