510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980113Substantially Equivalent

Wallstent Enteral Endoprosthesis

Boston Scientific Corporation, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980113 is the FDA 510(k) clearance record for WALLSTENT ENTERAL ENDOPROSTHESIS, a class II device, cleared for Boston Scientific Scimed, Inc. on under FDA product code MUM (Stent, Metallic, Expandable, Duodenal). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K980113.

Clearance record

Decision date
Received
(80 days to decision)
Product code
MUM Stent, Metallic, Expandable, Duodenal
Regulation
21 CFR 878.3610
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Boston Scientific Scimed, Inc. 5905 Nathan Ln., Plymouth MN
510(k) summary
Summary
Third party review
No

Clearances, product code MUM

Trailing 12 months

FDA records hold no clearances under product code MUM in the trailing twelve months.

FDA records show no clearances under product code MUM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MUM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260