Company ยท US
Katalyst Surgical, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2022. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
12recalls (12 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2022 | K213610 | Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper For Katalyst Surgical, LLC | GEI |
| Jun 19, 2020 | K192963 | Kogent Torus Ultrasonic Aspirator Katalyst Surgical, LLC | LFL |
| Jun 15, 2017 | K163632 | Katalyst Cyclophotocoagulation Probe Katalyst Surgical, LLC | LQJ |
| Apr 9, 2015 | K141781 | KOGENT SPETZLER LIGHTED SUCTION TUBES Katalyst Surgical, LLC | HBI |
| Sep 15, 2014 | K140362 | KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES Katalyst Surgical, LLC | HQF |
| Dec 21, 2012 | K123172 | KOGENT BIPOLAR FORCEPS Katalyst Surgical, LLC | GEI |
| Sep 17, 2012 | K121187 | KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES Katalyst Surgical, LLC | HQF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27 Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25 Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27 Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25 Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23 Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25 Open, Classified |
HNR | None listed |
| May 6, 2026 | Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23 Open, Classified |
HNR | None listed |