Chrysalis Intelligence · Sponsors · Katalyst Surgical, LLC

Katalyst Surgical, LLC

Chesterfield, MO, US · 2 510(k) clearances · 12 recalls

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Total clearances
2
2020-06-19 → 2022-10-07
Last 12 months
0
Product codes
2
Most recent
2022-10-07
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 1 2022-10-07
LFL Instrument, Ultrasonic Surgical Unclassified Unknown 1 2020-06-19
Safety

Recalls (12)

Class I (serious)
0
Risk of injury / death
Total recalls
12
Currently ongoing
12
Most recent
2026-03-25
DateSeverityStatusRecall # ProductCodeReason
2026-03-25 Class II Ongoing 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 ey…
2026-03-25 Class II Ongoing 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.
2026-03-25 Class II Ongoing 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.
2026-03-25 Class II Ongoing 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.
2026-03-25 Class II Ongoing 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.
2026-03-25 Class II Ongoing 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.
2026-03-25 Class II Ongoing 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.
2026-03-25 Class II Ongoing 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.
2026-03-25 Class II Ongoing 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.
2026-03-25 Class II Ongoing 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.
2026-03-25 Class II Ongoing 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.
2026-03-25 Class II Ongoing 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.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2022-10-07 K213610 Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps GEI Class II General, Plastic Surgery
2020-06-19 K192963 Kogent Torus Ultrasonic Aspirator LFL Unclassified Unknown
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence