Wallstent Enteral Endoprosthesis
FDA 510(k) K980113 · Boston Scientific Scimed, Inc.
510(k) numberK980113
Submission
- Device name
- Wallstent Enteral Endoprosthesis
- Applicant
- Boston Scientific Scimed, Inc.
Plymouth, MN, US - Received
- January 13, 1998
- Decision date
- April 3, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MUM – Stent, Metallic, Expandable, Duodenal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3610
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code MUM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentMUM · Special | Taewoong Medical Co., Ltd. | 03/31/2025SE |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort StentMUM · Traditional | Taewoong Medical Co., Ltd. | 06/14/2023SE |
| K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredMUM · Traditional | Cook Ireland, Ltd. | 05/04/2017SE |
| K101530 | Evolution Duodenal Stent System, Model EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-DMUM · Traditional | Cook Ireland, Ltd. | 03/29/2011SE |
| K062750 | Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models M00565010…MUM · Traditional | Boston Scientific Corp | 12/04/2006SE |
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|---|---|---|
| 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 Endoprosthesis cleared by the FDA?
Wallstent Enteral Endoprosthesis (K980113) received a 510(k) decision of Substantially Equivalent on April 3, 1998, 80 days after the submission was received.
What is the product code of K980113?
The FDA product code is MUM – Stent, Metallic, Expandable, Duodenal, a Class II (moderate risk) device regulated under 21 CFR 878.3610.