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
115
Registration Numbers
116
Same Product Code
156
Applicant Total
74
Review Days
94
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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
Other 510(k) clearances with the same product code (LFL), ordered by most recent decision date.
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Ultrasonic Surgical System
FDA 510(k)
FDA Unclassified
·Unknown
CUSA Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
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