FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Sonopet 1Q 3 7cm 1Q Large
K Number: K223770
·
Decision Feb 16, 2023
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
81
Review Days
63
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Basic Information
- Device Name
- Sonopet 1Q 3 7cm 1Q Large
- K Number
- K223770
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Corporation
- Date Received
- December 15, 2022
- Decision Date
- February 16, 2023
- 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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CUSA® Clarity Ultrasonic Surgical Aspirator System
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