Kogent Torus Ultrasonic Aspirator— 510(k) K192963
Substantially EquivalentKatalyst Surgical, LLC
FDA 510(k) clearance K192963 for Kogent Torus Ultrasonic Aspirator, Substantially Equivalent on 2020-06-19. Applicant: Katalyst Surgical, LLC. Device class: Unclassified.
Clearance details
- Applicant
- Katalyst Surgical, LLC
- Product code
- Code LFL
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chesterfield, MO, US
Recent devices under product code LFL
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view all- K213610 — Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps
- K163632 — Katalyst Cyclophotocoagulation Probe
- K141781 — KOGENT SPETZLER LIGHTED SUCTION TUBES
- K140362 — KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES
- K123172 — KOGENT BIPOLAR FORCEPS
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.