Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007495879

FEI Number

3007495879

Entity Name

THERMEDX, LLC

City/State/Country

Solon, OH, US

Establishment Address

31200 Solon Road, Unit 1, Solon, OH 44139, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

STRYKER CORP. (Owner Number: 1811755)

Owner / Operator Contact Address

4100 East Milham Ave., Kalamazoo, MI 49001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172048

PMA Number

N/A

All Registered Proprietary Names

P01790 ThermaClear Inflow Tube Set LL0004 FluidSmart Inflow/Outflow Tube Set P01918 ThermaClear Scope Outflow Tube Set LL0002 FluidSmart Inflow Tube Set LL0006 FluidSmart Urology Tube Set P2000 FluidSmart Fluid Management system (at the time of clearance, this was called Thermedx Fluid Management System LL0002 Luer Lock Set Single Lumen LL0004 - Tubing Set Single Lumen Inflow with Dual Outflow LL0006 - Urology Set P2000 FluidSmart Fluid Management system LL0002 Luer Lock Set Single Lumen LL0004 - Tubing Set Single Lumen Inflow with Dual Outflow

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NVT	Tubing And Tubing/Filter Fits	Obstetrics/Gynecology	Class 1	884.1700	2025-06-27
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2022-04-21
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2022-04-21
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2022-04-21
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2022-04-21
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2022-04-21
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2022-04-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STRYKER CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003897776	BIOMIMETIC THERAPEUTICS,LLC	FRANKLIN, TN, US
3040801290	Inari Medical, Costa Rica S.A.	Grecia Alajuela, CR
2031049	TMJ Solutions, LLC	San Buenaventura, CA, US
3016573902	Ortho-Space Ltd.	Caesarea Haifa, IL
3010411911	POM Medical, LLC	Moorpark, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K905706	Circon Acmi	GYN-1500 HYSTEROSCOPIC INUFFLATOR	1991-02-28
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

Similar Registrations

Registration Number	Establishment Name	Location
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US
9614434	STORZ ENDOSKOP PRODUKTIONS GMBH	SCHAFFHAUSEN, CH
3009420598	Primo Medical Group, Inc	W Bridgewater, MA, US
3013831261	Anhui Shiyin Photoelectric Instrument Co., Ltd.	Suzhou Anhui, CN
3010707607	KARL STORZ SE & CO. KG	NEUHAUSEN OBECK Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007495879. Last updated year: 2026. Please use registration number 3007495879 when referencing this establishment in official correspondence.