Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008791915

FEI Number

3008791915

Entity Name

Medeologix LLC

City/State/Country

San Jose, CA, US

Establishment Address

2200 ZANKER RD STE F, San Jose, CA 95131, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Medeologix LLC (Owner Number: 10033936)

Owner / Operator Contact Address

2200 Zanker Rd, Unit F, San Jose, CA 95131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iNAP One Sleep Therapy System SeptAlign Prodeon Urethral Sheath System Urocross Expander System (Model Numbers ES2018 and ES3025) Magnetic Surgical System QuantaFlo Pulse Biosciences IRRAflow CNS System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OZR	Intraoral Pressure Gradient Device	Dental	Class 2	872.5570	2023-11-01
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Ear, Nose, Throat	Class 2	874.3620	2026-03-03
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-04-08
QKA	Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia	Gastroenterology, Urology	Class 2	876.5510	2026-04-08
PNL	Magnetic Surgical System	General, Plastic Surgery	Class 2	878.4815	2018-08-06
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Cardiovascular	Class 2	870.2780	2016-01-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-04-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-10-30
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2018-10-30

Official Correspondent

Shawn Davis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medeologix LLC

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
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
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

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

Similar Registrations

Registration Number	Establishment Name	Location
3017791238	Somnics Health	Redwood City, CA, US
3014674517	SOMNICS, INC.	Zhubei City Hsinchu, TW
3007225047	HEMOSTASIS, LLC	Saint Paul, MN, US
1450662	Isomedix Operations, Inc.	Libertyville, IL, US
3012448339	STERI-TEK	Fremont, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008791915. Last updated year: 2026. Please use registration number 3008791915 when referencing this establishment in official correspondence.