AULEA MEDICAL, INC.

FDA Device Registration & Listing · Pleasanton, CA, US · Registration 3028977843

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
3028977843
FEI Number
3028977843
Entity Name
AULEA MEDICAL, INC.
City/State/Country
Pleasanton, CA, US
Establishment Address
5627 Stoneridge Dr Ste 312, Pleasanton, CA 94588, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Aulea Medical, Inc. (Owner Number: 10088655)
Owner / Operator Contact Address
5627 Stoneridge Dr., Suite 312, Pleasanton, CA 94588, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K191341
PMA Number
N/A

All Registered Proprietary Names

Veloxion Fluid Control Set (PN 1327) Veloxion Controller Kit (PN 2516) Veloxion Resectoscope (PN 2490) Veloxion Roll Stand (PN 2517) Waste Management Tubing (PN 1878) Tissue Catch (PN 1877) Veloxion

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KQT Evacuator, Gastro-Urology Gastroenterology, Urology Class 2 876.4370 2023-09-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-09-18
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2023-09-18
KQT Evacuator, Gastro-Urology Gastroenterology, Urology Class 2 876.4370 2023-09-18
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2023-09-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-09-18

Official Correspondent

George Hsu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Aulea 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
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 3028977843. Last updated year: 2026. Please use registration number 3028977843 when referencing this establishment in official correspondence.
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