GALVANIZE THERAPEUTICS

FDA Device Registration & Listing · Redwood City, CA, US · Registration 3017185164

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
3017185164
FEI Number
3017185164
Entity Name
GALVANIZE THERAPEUTICS
City/State/Country
Redwood City, CA, US
Establishment Address
3200 Bridge Parkway, Redwood City, CA 94065, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Galvanize Therapeutics (Owner Number: 10083741)
Owner / Operator Contact Address
3200 Bridge Parkway, Redwood City, CA 94065, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K253826
PMA Number
N/A

All Registered Proprietary Names

Galvanize Cart Aliya System INUMI Flex Needle Aliya EX System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment) Anesthesiology Class 1 868.6175 2026-01-09
OAB Low Energy Direct Current Thermal Ablation System General, Plastic Surgery Class 2 878.4400 2023-06-27
OAB Low Energy Direct Current Thermal Ablation System General, Plastic Surgery Class 2 878.4400 2024-05-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-05-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-05-11
OAB Low Energy Direct Current Thermal Ablation System General, Plastic Surgery Class 2 878.4400 2026-05-11

Official Correspondent

Deb Sheffield

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Galvanize Therapeutics
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
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017185164. Last updated year: 2026. Please use registration number 3017185164 when referencing this establishment in official correspondence.
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