TORUS Ultrasonic Aspirator System +1 more— 510(k) K261361
Substantially EquivalentCarl Zeiss Meditec, AG
FDA 510(k) clearance K261361 for TORUS Ultrasonic Aspirator System +1 more, Substantially Equivalent on 2026-10-15. Applicant: Carl Zeiss Meditec, AG. Device class: Unclassified.
Clearance details
- Device name as filed
- TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORUS Handpieces, TORUS Tip Packs, TORUS Tip Clearing Stylet)
- Applicant
- Carl Zeiss Meditec, AG
- Product code
- Product code LFL
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oberkochen, DE
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More clearances from Carl Zeiss Meditec, AG
view allAdverse 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.