510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062750Substantially Equivalent

Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models M00565010, M00565020, M00565030

Boston Scientific Corporation, Marlborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062750 is the FDA 510(k) clearance record for WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030, a class II device, cleared for Boston Scientific Corp on under FDA product code MUM (Stent, Metallic, Expandable, Duodenal). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K062750.

Clearance record

Decision date
Received
(81 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 Corp One Boston Scientific Way, Marlborough MA
510(k) summary
Summary PDF
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