Katalyst Surgical, LLC
FDA Regulatory Profile
Katalyst Surgical, LLC appears in FDA public data with 12 recalls, 7 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2073-2026, Class II) was initiated on March 25, 2026. Its most recent 510(k) clearance was granted on October 7, 2022.
Summary
- Total Recalls
- 12
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2073-2026 | Class II | DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23 | March 25, 2026 |
| Z-2074-2026 | Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25 | March 25, 2026 |
| Z-2072-2026 | Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S | March 25, 2026 |
| Z-2069-2026 | Class II | DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23 | March 25, 2026 |
| Z-2079-2026 | Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S | March 25, 2026 |
| Z-2075-2026 | Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25 | March 25, 2026 |
| Z-2070-2026 | Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25 | March 25, 2026 |
| Z-2076-2026 | Class II | DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27 | March 25, 2026 |
| Z-2080-2026 | Class II | DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27 | March 25, 2026 |
| Z-2078-2026 | Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25 | March 25, 2026 |
| Z-2071-2026 | Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF40 | March 25, 2026 |
| Z-2077-2026 | Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25 | March 25, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213610 | Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Ill | October 7, 2022 |
| K192963 | Kogent Torus Ultrasonic Aspirator | June 19, 2020 |
| K163632 | Katalyst Cyclophotocoagulation Probe | June 15, 2017 |
| K141781 | KOGENT SPETZLER LIGHTED SUCTION TUBES | April 9, 2015 |
| K140362 | KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMI | September 15, 2014 |
| K123172 | KOGENT BIPOLAR FORCEPS | December 21, 2012 |
| K121187 | KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES | September 17, 2012 |