# Elucent Medical, Inc.

- Location (FDA's records): Eden Prairie, MN
- FDA decisions: 4 (2018–2026): 4 510(k) clearances
- Names in FDA's records: Elucent Medical, Inc. (3); Elucent Medical (1)
- Product codes: NEU (3), EOQ (1)
- 510(k) review time since 2016: median 95 days, against 178 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 1 (1 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
- Focal Therapeutics: 2 (https://510kreport.com/company/focal-therapeutics)
- Cianna Medical, Inc.: 1 (https://510kreport.com/company/cianna-medical)
- Covidien: 1 (https://510kreport.com/company/covidien)

## Its most-cited devices
- K180640: SmartClip Soft Tissue Marker (2018), cited by 1

## Recent decisions
- K260565: SmartClip Delivery Catheter (ADR-1715) (May 14, 2026)
- K233639: SmartClip Secure Soft Tissue Marker (Dec 20, 2024)
- K183400: EnVisio Navigation Sytem (Mar 22, 2019)
- K180640: SmartClip Soft Tissue Marker (Jun 4, 2018)

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