Home / Companies / Katalyst Surgical, LLC

Katalyst Surgical, LLC

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
7
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2078-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25March 25, 2026
Z-2069-2026Class IIDEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23March 25, 2026
Z-2070-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25March 25, 2026
Z-2073-2026Class IIDEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23March 25, 2026
Z-2072-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-SMarch 25, 2026
Z-2080-2026Class IIDEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27March 25, 2026
Z-2076-2026Class IIDEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27March 25, 2026
Z-2074-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25March 25, 2026
Z-2079-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-SMarch 25, 2026
Z-2075-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25March 25, 2026
Z-2071-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF40March 25, 2026
Z-2077-2026Class IIDEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25March 25, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K213610Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable IllOctober 7, 2022
K192963Kogent Torus Ultrasonic AspiratorJune 19, 2020
K163632Katalyst Cyclophotocoagulation ProbeJune 15, 2017
K141781KOGENT SPETZLER LIGHTED SUCTION TUBESApril 9, 2015
K140362KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMISeptember 15, 2014
K123172KOGENT BIPOLAR FORCEPSDecember 21, 2012
K121187KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBESSeptember 17, 2012