Data / Medical devices / United States / Katalyst Surgical, LLC
Katalyst Surgical, LLC: FDA-registered device maker in Chesterfield, MO, United States, 6 510(k) clearances
Katalyst Surgical, LLC is registered with the FDA (registration 3007589150) in Chesterfield, MO, United States. It lists 36 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 7, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007589150
- Address
- 722 Goddard Ave, Chesterfield, MO, United States, 63005
- Owner or operator
- Katalyst Surgical, LLC (10029103)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 8, 2010
- Registered through
- 2026
- Brand names listed
- "J" Shaped Hydrodissetion Cannula, 150deg Tip, 16ga Outer Sleeve, 21ga Closed Inner Cannula Tip w/ .3mm Aspirating Port, 19ga Foreign Body Forceps, 3 French, 120mm Lighted Suction Tube, 3 French, 140mm Lighted Suction Tube, 3 French, 160mm Lighted Suction Tube, 45 degree Angled Curette, 45deg Tip, 16ga Outer Sleeve, 21ga Closed Inner Cannula Tip w/ .3mm Aspirating Port and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Caliper, Ophthalmic | HOE | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Cannula, Ophthalmic | HMX | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Depressor, Orbital | HNX | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Dilator, Lachrymal | HNW | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Elevator | HTE | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Endoilluminator | MPA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Forceps | HTD | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Hook, Ophthalmic | HNQ | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Illuminator, Fiberoptic, Surgical Field | HBI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Image, Illumination, Fiberoptic, For Endoscope | FFS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Laser, Ophthalmic | HQF | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Lens, Surgical, Laser, Accesssory, Ophthalmic Laser | LQJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Light, Surgical, Fiberoptic | FST | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Marker, Ocular | HMR | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Photocoagulator And Accessories | HQB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Punch, Corneo-Scleral | HNJ | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Manufacturer | accessdata.fda.gov |
| Retractor, Ophthalmic | HNI | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Ring, Ophthalmic (Flieringa) | HNH | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Specula, Ophthalmic | HNC | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Trabeculotome | HMZ | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 7, 2022 | K213610 | Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps | GEI | Substantially Equivalent | Katalyst Surgical, LLC | accessdata.fda.gov |
| June 15, 2017 | K163632 | Katalyst Cyclophotocoagulation Probe | LQJ | Substantially Equivalent | Katalyst Surgical, LLC | accessdata.fda.gov |
| April 9, 2015 | K141781 | KOGENT SPETZLER LIGHTED SUCTION TUBES | HBI | Substantially Equivalent | Katalyst Surgical, LLC | accessdata.fda.gov |
| September 15, 2014 | K140362 | KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES | HQF | Substantially Equivalent | Katalyst Surgical, LLC | accessdata.fda.gov |
| December 21, 2012 | K123172 | KOGENT BIPOLAR FORCEPS | GEI | Substantially Equivalent | Katalyst Surgical, LLC | accessdata.fda.gov |
| September 17, 2012 | K121187 | KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES | HQF | Substantially Equivalent | Katalyst Surgical, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 25, 2026 | 98660 | Class II | Ongoing | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Hook, Ophthalmic
- All makers of Caliper, Ophthalmic
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Knife, Ophthalmic
- All makers of Punch, Corneo-Scleral
- All makers of Curette, Surgical, General Use
Updated May 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.