MedWaves, Inc

FDA Device Registration & Listing · San Diego, CA, US · Registration 3005382058

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005382058
FEI Number
3005382058
Entity Name
MedWaves, Inc
City/State/Country
San Diego, CA, US
Establishment Address
16760 West Bernardo Drive, San Diego, CA 92127, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MedWaves (Owner Number: 10028164)
Owner / Operator Contact Address
16760 W Bernardo Drive, San Diego, CA 92127, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K143203
PMA Number
N/A

All Registered Proprietary Names

Avecure Microwave Ablation System AveCure Microwave Ablation System

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 2022-12-19
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2016-04-06

Official Correspondent

Daniel Yeh

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MedWaves
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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 3005382058. Last updated year: 2026. Please use registration number 3005382058 when referencing this establishment in official correspondence.
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