Evolution Colonic Stent System
FDA 510(k) K113510 · Cook Ireland, Ltd.
510(k) numberK113510
Submission
- Device name
- Evolution Colonic Stent System
- Applicant
- Cook Ireland, Ltd.
Limerick, IE - Received
- November 28, 2011
- Decision date
- May 17, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQR – Stent, Colonic, Metallic, Expandable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3610
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code MQR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent…MQR · Special | Boston Scientific Corporation | 03/08/2024SE |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corporation | 08/17/2020SE |
| K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal…MQR · Traditional | Boston Scientific Corporation | 04/17/2020SE |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN)MQR · Special | M.I.Tech Co., Ltd. | 03/07/2019SE |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)MQR · Traditional | M.I.Tech Co., Ltd. | 01/10/2019SE |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)MQR · Traditional | M.I.Tech Co., Ltd. | 11/02/2018SE |
| K061877 | Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corp | 09/15/2006SE |
| K060323 | Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380MQR · Traditional | Boston Scientific Corporation | 05/12/2006SE |
| K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corp | 09/30/2004SE |
| K030769 | Ultraflex Precision Colonic StentMQR · Traditional | Boston Scientific Corp | 07/14/2003SE |
More from Boston Scientific Corp
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| K233079 | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen®…FGE · Traditional | 06/14/2024SE |
| K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG · Traditional | 05/30/2023SE |
| K213946 | Compass BDS Biliary StentFGE · Traditional | 05/09/2022SE |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional | 05/20/2021SE |
| K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary StentFGE · Special | 11/16/2018SESU |
| K180868 | Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary…FGE · Traditional | 07/06/2018SE |
| K172057 | Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing…FGE · Traditional | 03/09/2018SE |
| K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary…FGE · Traditional | 02/27/2018SE |
Questions and answers
When was Evolution Colonic Stent System cleared by the FDA?
Evolution Colonic Stent System (K113510) received a 510(k) decision of Substantially Equivalent on May 17, 2012, 171 days after the submission was received.
What is the product code of K113510?
The FDA product code is MQR – Stent, Colonic, Metallic, Expandable, a Class II (moderate risk) device regulated under 21 CFR 878.3610.