Chrysalis Intelligence · Sponsors · Cook Ireland, Ltd.

Cook Ireland, Ltd.

Limerick, IE · 6 510(k) clearances · 30 PMAs

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Total clearances
6
2021-05-20 → 2026-07-24
Last 12 months
1
Product codes
3
Most recent
2026-07-24
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FCG Biopsy Needle Class II Gastroenterology, Urology 3 2024-07-29
FGE Stents, Drains And Dilators For The Biliary Ducts Class II Gastroenterology, Urology 2 2024-06-14
KTI Bronchoscope Accessory Class II Ear, Nose, Throat 1 2026-07-24
Class III

PMA approvals (30)

Total PMA records
30
Originals + supplements
Distinct product codes
4
First decision
2020-02-07
Most recent
2026-04-14
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-04-14 P200023-S009 Zilver® Vena® Venous Self-Expanding Stent 30-Day Notice QAN Stent, Iliac Vein Unknown
2026-04-14 P050017-S026 Zilver® Flex® 35 Vascular Stent; Zilver® 635® Vascular Stent; Zilver® 518® Vascular Stent 30-Day Notice NIO Stent, Iliac Unknown
2026-03-25 P100022-S045 Zilver® PTX® Drug-Eluting Peripheral Stent 30-Day Notice NIU Stent, Superficial Femoral Artery, Drug-Eluting Unknown
2025-10-22 P050017-S025 Zilver Flex® 35 Vascular Stent Special (Immediate Track) NIO Stent, Iliac Unknown
2025-07-03 P100022-S044 Zilver® PTX® Peripheral Drug-Eluting Stent 30-Day Notice NIU Stent, Superficial Femoral Artery, Drug-Eluting Unknown
2025-07-01 P050017-S024 Zilver Flex(R) 35 Vascular Stent Panel Track NIP Stent, Superficial Femoral Artery Unknown
2024-12-20 P100022-S043 Zilver PTX Peripheral Drug-Eluting Stent 30-Day Notice NIU Stent, Superficial Femoral Artery, Drug-Eluting Unknown
2024-05-14 P200023-S008 Zilver Vena® Venous Self-Expanding Stent 30-Day Notice QAN Stent, Iliac Vein Unknown
2024-05-14 P050017-S023 Zilver® Vascular Stent 30-Day Notice NIO Stent, Iliac Unknown
2024-02-08 P200023-S007 Zilver Vena Venous Self-Expanding Stent Normal 180 Day Track QAN Stent, Iliac Vein Unknown
2023-09-22 P200023-S006 Zilver Vena® Venous Self-Expanding Stent 30-Day Notice QAN Stent, Iliac Vein Unknown
2023-09-22 P100022-S042 Zilver® PTX® Peripheral Drug- Eluting Stent 30-Day Notice NIU Stent, Superficial Femoral Artery, Drug-Eluting Unknown
2023-09-22 P050017-S022 Zilver® Vascular Stent 30-Day Notice NIO Stent, Iliac Unknown
2023-04-10 P200023-S005 Zilver Vena Venous Self-Expanding Stent 30-Day Notice QAN Stent, Iliac Vein Unknown
2023-03-16 P200023-S004 Zilver Vena® Venous Self-Expanding Stent 30-Day Notice QAN Stent, Iliac Vein Unknown
2023-03-16 P100022-S041 Zilver® PTX® Peripheral Drug-Eluting Stent 30-Day Notice NIU Stent, Superficial Femoral Artery, Drug-Eluting Unknown
2023-03-16 P050017-S021 Zilver® Vascular Stent 30-Day Notice NIO Stent, Iliac Unknown
2023-02-22 P200023-S003 Zilver Vena® Venous Self Expanding Stent 30-Day Notice QAN Stent, Iliac Vein Unknown
2023-02-22 P050017-S020 Zilver® Vascular Stent 30-Day Notice NIO Stent, Iliac Unknown
2022-05-13 P100022-S039 Zilver® PTX® Drug-Eluting Peripheral Stent 135 Review Track For 30-Day Notice NIU Stent, Superficial Femoral Artery, Drug-Eluting Unknown
2022-04-04 P050017-S019 Zilver Vascular Stent 30-Day Notice NIO Stent, Iliac Unknown
2022-02-02 P100022-S040 Zilver® PTX® Drug-Eluting Peripheral Stent Real-Time Process NIU Stent, Superficial Femoral Artery, Drug-Eluting Unknown
2021-11-02 P100022-S038 Zilver® PTX® Drug-Eluting Peripheral Stent Normal 180 Day Track No User Fee NIU Stent, Superficial Femoral Artery, Drug-Eluting Unknown
2021-10-26 P200023-S002 Zilver Vena Venous Self-Expanding Stent 30-Day Notice QAN Stent, Iliac Vein Unknown
2021-10-01 P200023-S001 Zilver Vena Venous Self-Expanding Stent Special (Immediate Track) QAN Stent, Iliac Vein Unknown
2020-12-22 P100022-S037 Zilver PTX Drug-Eluting Peripheral Stent 30-Day Notice NIU Stent, Superficial Femoral Artery, Drug-Eluting Unknown
2020-10-09 P200023 Zilver Vena Venous Self-Expanding Stent Original QAN Stent, Iliac Vein Unknown
2020-07-31 P100022-S036 Zilver PTX Drug-Eluting Peripheral Stent 30-Day Notice NIU Stent, Superficial Femoral Artery, Drug-Eluting Unknown
2020-05-15 P100022-S035 Zilver PTX Drug-Eluting Peripheral Stent 30-Day Notice NIU Stent, Superficial Femoral Artery, Drug-Eluting Unknown
2020-02-07 P050017-S018 Zilver Vascular Stent 30-Day Notice NIO Stent, Iliac Unknown
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2026-07-24 K261274 EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes KTI Class II Ear, Nose, Throat
2024-07-29 K241209 EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) FCG Class II Gastroenterology, Urology
2024-06-14 K233079 Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) FGE Class II Gastroenterology, Urology
2023-05-30 K230909 EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) FCG Class II Gastroenterology, Urology
2022-05-09 K213946 Compass BDS Biliary Stent FGE Class II Gastroenterology, Urology
2021-05-20 K210476 EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle FCG Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-08-18 09:10 · Last ingest 2026-08-18T13:09:43.467718 · Pipeline: Chrysalis Intelligence