Sonopet iQ Ultrasonic Aspirator System (5500-050-000)— 510(k) K243930
Substantially EquivalentStryker Instruments
FDA 510(k) clearance K243930 for Sonopet iQ Ultrasonic Aspirator System (5500-050-000), Substantially Equivalent on 2025-03-24. Applicant: Stryker Instruments. Device class: Unclassified.
Clearance details
- Applicant
- Stryker Instruments
- Product code
- Product code LFL
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portage, MI, US
Recent devices under product code LFL
view all- K261361 — TORUS Ultrasonic Aspirator System +1 more
- K262244 — Sonopet iQ Series III Console (5700-050-000) +6 more
- K261448 — neXus Ultrasonic Surgical Aspirator System
- K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K242894 — SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10) +4 more
More clearances from Stryker Instruments
view all- K262386 — SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000) +1 more
- K261959 — Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) +3 more
- K261544 — Hydro Irrigation System
- K253679 — Hydro Irrigation System
- K252282 — SurgiCount+ System
Adverse events under product code LFL
product code LFL- Death
- 29
- Injury
- 1,046
- Malfunction
- 21,642
- Total
- 22,717
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.