EVOLUTION BILIARY STENT SYSTEM— 510(k) K121430
UnknownCook Ireland, Ltd.
FDA 510(k) clearance K121430 for EVOLUTION BILIARY STENT SYSTEM, Unknown on 2013-03-01. Applicant: Cook Ireland, Ltd.. Device class: 2.
Clearance details
- Applicant
- Cook Ireland, Ltd.
- Product code
- Code FGE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Limerick, IE
Recent devices under product code FGE
view all- K260835 — ARCHIMEDES Biodegradable Stent (Medium)
- K253393 — Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019
- K253832 — Dilation Balloon Catheter
- K251658 — Endoflux Biliary & Pancreatic Stent Sets
- K253987 — BARE Wireguided Balloon Dilation Catheter (1235)
More clearances from Cook Ireland, Ltd.
view all- K261274 — EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes +1 more
- K241209 — EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)
- K233079 — Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS) +4 more
- K230909 — EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
- K213946 — Compass BDS Biliary Stent
Adverse events under product code FGE
product code FGE- Death
- 52
- Injury
- 2,347
- Malfunction
- 9,798
- Other
- 1
- Total
- 12,198
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.