Wallstent Enteral Endoprothesis
FDA 510(k) K954290 · Boston Scientific Scimed, Inc.
510(k) numberK954290
Submission
- Device name
- Wallstent Enteral Endoprothesis
- Applicant
- Boston Scientific Scimed, Inc.
Plymouth, MN, US - Received
- September 14, 1995
- Decision date
- July 10, 1996
- 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 |
| K113510 | Evolution Colonic Stent SystemMQR · Traditional | Cook Ireland, Ltd. | 05/17/2012SE |
| 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 |
More from Boston Scientific Corp
| 510(k) | Device | Decision |
|---|---|---|
| K041727 | Modification to Atlantis PV Imaging Catheter, Model 36456OBJ · Special | 07/23/2004SE |
| K030617 | PT2 Guide Wire and Addwire Extension WireDQX · Abbreviated | 05/21/2003SE |
| K024048 | Modification to Boston Scientific Express Biliary LD Premounted Stent SystemFGE · Special | 01/06/2003SESU |
| K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterDQY · Traditional | 08/08/2002SE |
| K021901 | Wallgraft Tracheobronchial Endoprothesis with Unistep Plus Delivery SystemJCT · Special | 07/09/2002SE |
| K012822 | Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model…FGE · Special | 10/24/2001SESU |
| K012216 | Niroyal Biliary Premounted Stent SystemFGE · Special | 08/17/2001SESU |
| K000743 | Boston Scientific Scimed Atlantis Coronary Imaging Catheter, Model C4020DQO · Traditional | 09/06/2000SE |
| K000001 | Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery SystemJCT · Traditional | 06/05/2000SE |
| K000956 | Modification to Scimed 6F Impulse Angiographic CathatersDQO · Special | 04/21/2000SE |
Questions and answers
When was Wallstent Enteral Endoprothesis cleared by the FDA?
Wallstent Enteral Endoprothesis (K954290) received a 510(k) decision of Substantially Equivalent on July 10, 1996, 300 days after the submission was received.
What is the product code of K954290?
The FDA product code is MQR – Stent, Colonic, Metallic, Expandable, a Class II (moderate risk) device regulated under 21 CFR 878.3610.