510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223067Substantially Equivalent

Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent

Taewoong Medical Co., Ltd., Gimpo-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223067 is the FDA 510(k) clearance record for Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent, a class II device, cleared for Taewoong Medical Co., Ltd. on under FDA product code MUM (Stent, Metallic, Expandable, Duodenal). FDA records list 17 510(k) clearances for Taewoong Medical Co., Ltd., from to . As of , FDA records show no recalls naming K223067.

Clearance record

Decision date
Received
(264 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
Taewoong Medical Co., Ltd. 14 Gojeong-Ro, Wolgot-Myeon, Gimpo-Si, KR
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