Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered— 510(k) K163468
Substantially EquivalentCook Ireland, Ltd.
FDA 510(k) clearance K163468 for Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered, Substantially Equivalent on 2017-05-04. Applicant: Cook Ireland, Ltd.. Device class: 2.
Clearance details
- Applicant
- Cook Ireland, Ltd.
- Product code
- Code MUM
- Device class
- Class 2
- Regulation
- 21 CFR 878.3610
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Limerick, IE
Recent devices under product code MUM
view all- K250663 — Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
- K223067 — Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent
- K101530 — EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D
- K062750 — WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
- K980113 — WALLSTENT ENTERAL ENDOPROSTHESIS
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 MUM
product code MUM- Death
- 6
- Injury
- 137
- Total
- 143
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.