# Finemedix Co., Ltd.

- Location (FDA's records): Daegu, KR
- FDA decisions: 11 (2018–2026): 11 510(k) clearances
- Product codes: FCG (3), PKL (2), OCX (2), FBK (1), KTI (1), KGE (1), FDI (1)
- 510(k) review time since 2016: median 201 days, against 120 for FDA's reviews in the same codes and years (3 of 8 faster)
- Predicates its devices cite: 13 (3 its own); citations of its devices by later devices: 6 (3 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
- Olympus Medical Systems Corp.: 3 (https://510kreport.com/company/olympus-medical-systems)
- United States Endoscopy Group, Inc.: 2 (https://510kreport.com/company/united-states-endoscopy-group)
- Micro-Tech (Nanjing) Co., Ltd.: 1 (https://510kreport.com/company/micro-tech-nanjing)
- Medi-Globe Corp.: 1 (https://510kreport.com/company/medi-globe)
- Hangzhou AGS MedTech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-ags-medtech)
- Zhejiang Chuangxiang Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-chuangxiang-medical-technology)
- Cook Ireland, Ltd.: 1 (https://510kreport.com/company/cook-ireland)

## Firms that cite its devices most
- Incore Co., Ltd.: 2 (https://510kreport.com/company/incore)
- Yangzhou Fartley Medical Instrument Technology Co., Ltd.: 1 (https://510kreport.com/company/yangzhou-fartley-medical-instrument-technology)

## Its most-cited devices
- K202616: ClearCap Distal Attachment (2021), cited by 2
- K183021: ClearEndoclip (2019), cited by 2
- K231267: ClearTip (2023), cited by 1
- K183289: ClearGrasp Snare (2019), cited by 1

## Recent decisions
- K251478: ClearTip TBNA Type (Apr 16, 2026)
- K250994: ClearTip FNA and FNB Types (Aug 21, 2025)
- K242857: ClearHemograsper (May 21, 2025)
- K242134: ClearCap Distal Attachment (Aug 20, 2024)
- K231267: ClearTip (Jun 30, 2023)
- K202616: ClearCap Distal Attachment (Feb 19, 2021)
- K200217: ClearEndoclip (Oct 5, 2020)
- K183021: ClearEndoclip (Jun 28, 2019)

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