Katalyst Surgical, LLC
Medical device manufacturer in Chesterfield, MO.
7510(k) clearances
0PMA approvals
12recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K213610 | Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent…GEI · Traditional | 10/07/2022SE |
| K192963 | Kogent Torus Ultrasonic AspiratorLFL · Traditional | 06/19/2020SE |
| K163632 | Katalyst Cyclophotocoagulation ProbeLQJ · Traditional | 06/15/2017SE |
| K141781 | Kogent Spetzler Lighted Suction TubesHBI · Traditional | 04/09/2015SE |
| K140362 | Katalyst Revolver Laser Probes, Katalyst Revolver Illuminated Laser Probes, Katalyst…HQF · Traditional | 09/15/2014SE |
| K123172 | Kogent Bipolar ForcepsGEI · Traditional | 12/21/2012SE |
| K121187 | Katalyst Laser Probes, Katalyst Illuminated Laser ProbesHQF · Traditional | 09/17/2012SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2080-2026 Class II | DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number:…Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for… | 03/25/2026Open, Classified |
| Z-2079-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number:…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 03/25/2026Open, Classified |
| Z-2078-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number:…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 03/25/2026Open, Classified |
| Z-2077-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 03/25/2026Open, Classified |
| Z-2076-2026 Class II | DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 03/25/2026Open, Classified |
| Z-2075-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 03/25/2026Open, Classified |
| Z-2074-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number:…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 03/25/2026Open, Classified |
| Z-2073-2026 Class II | DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number:…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 03/25/2026Open, Classified |
| Z-2072-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number:…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 03/25/2026Open, Classified |
| Z-2071-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 03/25/2026Open, Classified |
| Z-2070-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number:…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 03/25/2026Open, Classified |
| Z-2069-2026 Class II | DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number:…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | 03/25/2026Open, Classified |