EVOLUTION COLONIC STENT SYSTEM— 510(k) K113510
Substantially EquivalentCook Ireland, Ltd.
FDA 510(k) clearance K113510 for EVOLUTION COLONIC STENT SYSTEM, Substantially Equivalent on 2012-05-17. Applicant: Cook Ireland, Ltd.. Device class: 2.
Clearance details
- Applicant
- Cook Ireland, Ltd.
- Product code
- Code MQR
- 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 MQR
view all- K234046 — WallFlex Colonic Stent System with Anchor Lock Delivery System +3 more
- K201159 — WallFlex Colonic Stent System with Anchor Lock Delivery System
- K200257 — WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
- K190141 — HANAROSTENT LowAx Colon/Rectum (NNN)
- K183616 — HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
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 MQR
product code MQR- Death
- 11
- Injury
- 149
- Total
- 160
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.