Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008769756

FEI Number

3008769756

Entity Name

NEUWAVE MEDICAL, INC.

City/State/Country

Madison, WI, US

Establishment Address

3529, 3513(Suite 100) and 3543 Anderson Street, Madison, WI 53704, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NeuWave Medical, Inc. (Owner Number: 10034016)

Owner / Operator Contact Address

3529 Anderson Street, Madison, WI 53704, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220472

PMA Number

N/A

All Registered Proprietary Names

NEUWAVE Microwave Ablation System and Accessories The Arm CT Mounting Brackets NEUWAVE Certus PRXT Ablation Probes NEUWAVE PR Ablation Probes Foot Switch Accessories NEUWAVE Certus Microwave Ablation System Certus LK Ablation Probes NEUWAVE PRXT Ablation Probes Certus 140 2.45GHz Ablation System NEUWAVE Certus PR Ablation Probes NEUWAVE Microwave Ablation System Certus PRXT Ablation Probes NEUWAVE LN Ablation Probes Certus LKXT Ablation Probes NEUWAVE PRS Ablation Probes NEUWAVE Certus LK Ablation Probes NEUWAVE LKXT Ablation Probes NEUWAVE Certus LKXT Ablation Probes Certus LN Ablation Probes Certus PR Ablation Probes Dual Probe Clips NEUWAVE LK Ablation Probes Certus SR Ablation Probes NEUWAVE SR Ablation Probes NEUWAVE Microwave Ablation

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2023-12-06
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2016-04-21
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2020-11-18
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-16

Official Correspondent

Eleanor Zhou

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NeuWave Medical, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0210-2022	Covidien Llc	2	Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008769756. Last updated year: 2026. Please use registration number 3008769756 when referencing this establishment in official correspondence.