Chrysalis Intelligence · Sponsors · Taewoong Medical Co., Ltd.

Taewoong Medical Co., Ltd.

Gyeonggi-Do, KR · 12 510(k) clearances

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Total clearances
12
2021-10-08 → 2026-05-21
Last 12 months
4
Product codes
5
Most recent
2026-05-21
Name variants in FDA filings: Taewoong Medical Co., Ltd. / Taewoong Medical
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
ESW Prosthesis, Esophageal Class II General, Plastic Surgery 4 2025-10-30
FGE Stents, Drains And Dilators For The Biliary Ducts Class II Gastroenterology, Urology 3 2025-12-29
KNS — — — 2 2026-05-21
MUM Stent, Metallic, Expandable, Duodenal Class II General, Plastic Surgery 2 2025-03-31
PCU — — — 1 2026-03-13
Filings

All 510(k) clearances (12)

Date K-number Device Code Class Specialty
2026-05-21 K260962 Sphincterotome KNS — —
2026-03-13 K252648 Niti-S SPAXUS Stent PCU — —
2025-12-29 K251123 Niti-S Biliary Stent; Niti-S Biliary Slim M Stent FGE Class II Gastroenterology, Urology
2025-10-30 K243619 Niti-S Esophageal Stent; Esophageal TTS Stent ESW Class II General, Plastic Surgery
2025-03-31 K250663 Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent MUM Class II General, Plastic Surgery
2024-03-22 K240522 Esophageal TTS Stent ESW Class II General, Plastic Surgery
2023-06-14 K223067 Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent MUM Class II General, Plastic Surgery
2023-05-26 K223626 Niti-S Biliary Speed D Stent FGE Class II Gastroenterology, Urology
2023-04-05 K223256 Optimos™ Cystotome KNS — —
2022-06-22 K221482 Esophageal TTS Stent ESW Class II General, Plastic Surgery
2022-06-09 K221071 Niti-S Biliary Slim M Stent FGE Class II Gastroenterology, Urology
2021-10-08 K211706 Esophageal TTS Stent ESW Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence