# Sejong Medical Co., Ltd.

- Location (FDA's records): Paju-Si, KR
- FDA decisions: 9 (2017–2026): 9 510(k) clearances
- Product codes: GEI (3), GCJ (3), HET (2), FYD (1)
- 510(k) review time since 2016: median 174 days, against 100 for FDA's reviews in the same codes and years (1 of 6 faster)
- Predicates its devices cite: 10 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mgb Endoskopische Gerate GmbH (Berlin): 2 (https://510kreport.com/company/mgb-endoskopische-gerate-berlin)
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)
- Conmedcorp: 1 (https://510kreport.com/company/conmedcorp)
- Pall Medical: 1 (https://510kreport.com/company/pall-medical)

## Firms that cite its devices most
- Jiangsu Haize Medical Scientific Development Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-haize-medical-scientific-development)

## Its most-cited devices
- K173112: LAP-iX (2017), cited by 2
- K173111: LAP-iX Suction Irrigation (2017), cited by 1
- K200639: LAP-iX (2021), cited by 1
- K171741: Laport (2017), cited by 1

## Recent decisions
- K253165: LAP-iX2N (Jun 9, 2026)
- K252985: Laport (May 19, 2026)
- K200639: LAP-iX (Sep 29, 2021)
- K200638: LAP-iX Suction Irrigation (Apr 3, 2020)
- K173108: Smoklean (May 18, 2018)
- K173111: LAP-iX Suction Irrigation (Nov 28, 2017)
- K173112: LAP-iX (Nov 21, 2017)
- K171726: LapBag (Sep 25, 2017)

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