Katalyst Surgical, LLC
Chesterfield, MO, US
KATALYST SURGICAL, LLC appears in FDA device records in Chesterfield, MO. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 12 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Katalyst Surgical, LLC between 2012 and 2022. The busiest year on record is 2012, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213610 | Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps | GEI | Substantially Equivalent | |
| K192963 | Kogent Torus Ultrasonic Aspirator | LFL | Substantially Equivalent | |
| K163632 | Katalyst Cyclophotocoagulation Probe | LQJ | Substantially Equivalent | |
| K141781 | KOGENT SPETZLER LIGHTED SUCTION TUBES | HBI | Substantially Equivalent | |
| K140362 | KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES | HQF | Substantially Equivalent | |
| K123172 | KOGENT BIPOLAR FORCEPS | GEI | Substantially Equivalent | |
| K121187 | KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES | HQF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007589150 | 3007589150 | KATALYST SURGICAL, LLC | 722 Goddard Ave, Chesterfield, MO 63005 US | 2026 | and 26 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HOECaliper, Ophthalmic
- HMXCannula, Ophthalmic
- MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
- FZSCurette, Surgical, General Use
- HNXDepressor, Orbital
- HNWDilator, Lachrymal
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HTEElevator
- MPAEndoilluminator
- HTDForceps
- HNRForceps, Ophthalmic
- GDFGuide, Needle, Surgical
- HNQHook, Ophthalmic
- GDGHook, Surgical, General & Plastic Surgery
- HBIIlluminator, Fiberoptic, Surgical Field
- FFSImage, Illumination, Fiberoptic, For Endoscope
- HCFInstrument, Ligature Passing And Knot Tying
- HAOInstrument, Surgical, Non-Powered
- LFLInstrument, Ultrasonic Surgical
- HNNKnife, Ophthalmic
- EMFKnife, Surgical
- HQFLaser, Ophthalmic
- LQJLens, Surgical, Laser, Accesssory, Ophthalmic Laser
- FSTLight, Surgical, Fiberoptic
- HMRMarker, Ocular
- HQBPhotocoagulator And Accessories
- HNJPunch, Corneo-Scleral
- GADRetractor
- HNIRetractor, Ophthalmic
- HNHRing, Ophthalmic (Flieringa)
- LRWScissors, General, Surgical
- HNFScissors, Ophthalmic
- HNDSpatula, Ophthalmic
- HNCSpecula, Ophthalmic
- HMZTrabeculotome
- LRPTray, Surgical
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2080-2026 | DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27 | Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box. | Class II | Open, Classified | |
| Z-2079-2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Open, Classified | |
| Z-2078-2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Open, Classified | |
| Z-2077-2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Open, Classified | |
| Z-2076-2026 | DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Open, Classified | |
| Z-2075-2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Open, Classified | |
| Z-2074-2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Open, Classified | |
| Z-2073-2026 | DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Open, Classified | |
| Z-2072-2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Open, Classified | |
| Z-2071-2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Open, Classified | |
| Z-2070-2026 | DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Open, Classified | |
| Z-2069-2026 | DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain