KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES— 510(k) K140362
Substantially EquivalentKatalyst Surgical, LLC
FDA 510(k) clearance K140362 for KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES, Substantially Equivalent on 2014-09-15. Applicant: Katalyst Surgical, LLC. Device class: 2.
Clearance details
- Applicant
- Katalyst Surgical, LLC
- Product code
- Code HQF
- Device class
- Class 2
- Regulation
- 21 CFR 886.4390
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chesterfield, MO, US
Recent devices under product code HQF
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- K192963 — Kogent Torus Ultrasonic Aspirator
- K163632 — Katalyst Cyclophotocoagulation Probe
- K141781 — KOGENT SPETZLER LIGHTED SUCTION TUBES
- K123172 — KOGENT BIPOLAR FORCEPS
Adverse events under product code HQF
product code HQF- Injury
- 166
- Other
- 1
- Total
- 167
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.