# Neuwave Medical, Inc.

- Location (FDA's records): Madision, WI
- FDA decisions: 15 (2010–2024): 15 510(k) clearances
- Product codes: NEY (10), JAK (4), LLZ (1)
- 510(k) review time since 2016: median 121 days, against 121 for FDA's reviews in the same codes and years (3 of 9 faster)
- Predicates its devices cite: 33 (25 its own); citations of its devices by later devices: 29 (25 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
- Valleylab, Inc.: 3 (https://510kreport.com/company/valleylab)
- Covidien Lp, Formerly Know AS Valleylab, A Divison: 1 (https://510kreport.com/company/covidien-lp-formerly-know-as-valleylab-a-divison)
- Endocare, Inc.: 1 (https://510kreport.com/company/endocare)
- Microsurgeon, Inc.: 1 (https://510kreport.com/company/microsurgeon)
- Radiotherapeutics Corp.: 1 (https://510kreport.com/company/radiotherapeutics)
- Perfint Healthcare Pvt, Ltd.: 1 (https://510kreport.com/company/perfint-healthcare-pvt)

## Firms that cite its devices most
- Varian Medical Systems, Inc.: 1 (https://510kreport.com/company/varian-medical-systems)
- Medwaves Incorporated: 1 (https://510kreport.com/company/medwaves)
- Covidien: 1 (https://510kreport.com/company/covidien)
- Mirada Medical, Ltd.: 1 (https://510kreport.com/company/mirada-medical)

## Its most-cited devices
- K100744: Certus 140 Microwave Ablation System and Accessories, Model Certus 140 (2010), cited by 6
- K113237: Certus 140 2.45GHZ Ablation System (2012), cited by 5
- K122217: Certus 140 2.45GHZ Ablation System (2012), cited by 4
- K130399: Certus 140 Certusurggt Surgical Tool (2013), cited by 3
- K200081: NEUWAVE Microwave Ablation System and Accessories (2020), cited by 2
- K150313: Ablation Confirmation (2015), cited by 2

## Recent decisions
- K232227: Ablate-IQ (Apr 4, 2024)
- K231738: NEUWAVE™ Microwave Ablation System and Accessories (Nov 16, 2023)
- K220472: NEUWAVE Microwave Ablation System and Accessories (Aug 11, 2022)
- K200081: NEUWAVE Microwave Ablation System and Accessories (Nov 13, 2020)
- K192427: Ablation Confirmation (Oct 3, 2019)
- K173756: Certus 140 2.45GHz Ablation System (Oct 24, 2018)
- K171022: Ablation Confirmation (May 9, 2017)
- K163118: FLEX Microwave Ablation System and Accessories (Mar 9, 2017)

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