WALLSTENT ENTERAL ENDOPROSTHESIS— 510(k) K980113
Substantially EquivalentBoston Scientific Scimed, Inc.
FDA 510(k) clearance K980113 for WALLSTENT ENTERAL ENDOPROSTHESIS, Substantially Equivalent on 1998-04-03. Applicant: Boston Scientific Scimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Scimed, Inc.
- 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
- Plymouth, MN, US
Recent devices under product code MUM
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- K163468 — Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
- 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
More clearances from Boston Scientific Scimed, Inc.
view all- K041727 — MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
- K030617 — PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
- K024048 — MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
- K021735 — BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
- K021901 — WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
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.