# Incore Co., Ltd.

- Location (FDA's records): Daegu, KR
- FDA decisions: 6 (2022–2024): 6 510(k) clearances
- Product codes: FBK (1), GCJ (1), QSY (1), PKL (1), OTJ (1), FDI (1)
- 510(k) review time since 2016: median 259 days, against 213 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 1 (0 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
- Finemedix Co., Ltd.: 2 (https://510kreport.com/company/finemedix)
- Micro-Tech (Nanjing) Co., Ltd.: 1 (https://510kreport.com/company/micro-tech-nanjing)
- Unimicro Medical Systems (Shenzhen) Co., Ltd.: 1 (https://510kreport.com/company/unimicro-medical-systems-shenzhen)
- Sam Medical Products: 1 (https://510kreport.com/company/sam-medical-products)
- Nelis: 1 (https://510kreport.com/company/nelis)

## Firms that cite its devices most
- Yuwonmeditech Co., Ltd.: 1 (https://510kreport.com/company/yuwonmeditech)

## Its most-cited devices
- K211148: CORE-Trocar (2022), cited by 1

## Recent decisions
- K232216: Hemoblock_S (Prescription); Hemoblock_S (OTC) (Apr 19, 2024)
- K221054: Core-Injector (Dec 21, 2022)
- K220846: Core-Snare (Nov 21, 2022)
- K220081: Core-Sport (Sep 28, 2022)
- K213338: Core-Clip (Jun 23, 2022)
- K211148: CORE-Trocar (Jun 21, 2022)

Source page: https://510kreport.com/company/incore