# Taewoong Medical Co., Ltd.

- Location (FDA's records): Gimpo-Si, KR
- FDA decisions: 17 (2005–2026): 17 510(k) clearances
- Names in FDA's records: Taewoong Medical Co., Ltd. (16); Taewoong Medical (1)
- Product codes: ESW (8), FGE (4), KNS (2), MUM (2), PCU (1)
- 510(k) review time since 2016: median 166 days, against 130 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 34 (19 its own); citations of its devices by later devices: 26 (19 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 9 (https://510kreport.com/company/boston-scientific)
- Wilson-Cook Medical, Inc.: 3 (https://510kreport.com/company/wilson-cook-medical)
- M.I.Tech Co., Ltd.: 3 (https://510kreport.com/company/mitech)

## Firms that cite its devices most
- Endochoice, Inc.: 3 (https://510kreport.com/company/endochoice)
- M.I.Tech Co., Ltd.: 2 (https://510kreport.com/company/mitech)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Thoracent, Inc.: 1 (https://510kreport.com/company/thoracent)

## Its most-cited devices
- K073667: Niti-S Biliary Stent (2008), cited by 6
- K080782: Niti-S Esophageal Stent (2009), cited by 5
- K123205: Esophageal TTS Stent (2013), cited by 4
- K041648: Niti-S Stent & Introducer, Model Eoxxxx (2005), cited by 3
- K113551: Esophageal TTS Stent (2012), cited by 3
- K221071: Niti-S Biliary Slim M Stent (2022), cited by 1

## Recent decisions
- K260962: Sphincterotome (May 21, 2026)
- K252648: Niti-S SPAXUS Stent (Mar 13, 2026)
- K251123: Niti-S Biliary Stent; Niti-S Biliary Slim M Stent (Dec 29, 2025)
- K243619: Niti-S Esophageal Stent; Esophageal TTS Stent (Oct 30, 2025)
- K250663: Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent (Mar 31, 2025)
- K240522: Esophageal TTS Stent (Mar 22, 2024)
- K223067: Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent (Jun 14, 2023)
- K223626: Niti-S Biliary Speed D Stent (May 26, 2023)

Source page: https://510kreport.com/company/taewoong-medical