FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K Number: K243930
·
Decision Mar 24, 2025
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
155
Applicant Total
15
Review Days
94
Basic Information
- Device Name
- Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
- K Number
- K243930
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Instruments
- Date Received
- December 20, 2024
- Decision Date
- March 24, 2025
- Product Code
- LFL
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
Similar 510(k) Clearances
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SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)
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