# Claronav, Inc.

- Location (FDA's records): Toronto, CA
- FDA decisions: 6 (2016–2025): 6 510(k) clearances
- Names in FDA's records: Claronav, Inc. (4); Claronav (2)
- Product codes: PLV (3), HAW (2), PGW (1)
- 510(k) review time since 2016: median 271 days, against 226 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 2 (2 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
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- X-Nav Technologies, LLC: 1 (https://510kreport.com/company/x-nav-technologies)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)

## Its most-cited devices
- K163439: NaviENT (2017), cited by 1
- K161406: Navident (2016), cited by 1

## Recent decisions
- K243053: Navient Image Guided Navigation System (ENT) (955-NC-NC) (Jun 20, 2025)
- K241327: Navient Image Guide Navigation System (955-NC-NC), Cranial (Feb 5, 2025)
- K233563: Navident (Jul 25, 2024)
- K210947: Navident (Jun 27, 2022)
- K163439: NaviENT (Sep 1, 2017)
- K161406: Navident (Sep 8, 2016)

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