# Nitiloop, Ltd.

- Location (FDA's records): Netanya, IL
- FDA decisions: 4 (2015–2020): 4 510(k) clearances
- Product codes: DQY (4)
- 510(k) review time since 2016: median 79 days, against 117 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 3 (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
- Roxwood Medical, Inc.: 1 (https://510kreport.com/company/roxwood-medical)
- Bridge Medical, Inc.: 1 (https://510kreport.com/company/bridge-medical)
- Asahi Intecc Co., Ltd.: 1 (https://510kreport.com/company/asahi-intecc)

## Its most-cited devices
- K143608: NovaCross Microcatheter (2015), cited by 2
- K160389: NovaCross Microcatheter (2016), cited by 1

## Recent decisions
- K193322: NovaCross CTO Microcatheter (Apr 2, 2020)
- K172297: NovaCross Microcatheter (Oct 18, 2017)
- K160389: NovaCross Microcatheter (Mar 11, 2016)
- K143608: NovaCross Microcatheter (May 4, 2015)

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