Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1450997

FEI Number

1450997

Entity Name

Northgate Technologies Inc.

City/State/Country

Elgin, IL, US

Establishment Address

1591 Scottsdale Court, Elgin, IL 60123, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Northgate Technologies, Inc. (Owner Number: 10092614)

Owner / Operator Contact Address

1591 Scottsdale Court, Elgin, IL 60123, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202813

PMA Number

N/A

All Registered Proprietary Names

72-00160-0 S&N HIGH FLOW TUBING 7-510-46 GENERAL USE 15/22mm TUBING 72-00123-0 OLYMPUS GENERAL USE TUB 72-00163-0 OLYMPUS UHI/UHI-2 TUBING 7-510-32 GENERAL USE BARB TUBING SET 7-510-15 GENERAL USE 15mm CONN 7-510-16 UNIVERSAL TUBING SET 7-510-28 NORTECH GENERAL USE TUBING AM-LS1 Adapter AM-BP1 Adapter AM-VY1 Adapter AM-2101 Activation Card AM-101 StimSite Signal Box AM-DA1 Adapter 7-510-63 NEBULAE SRS INFUSION STAND CLAMP 7-650-01 PUREPNEUMO Tubing Set 7-510-52 Insufflation Tubing, Gen Use Prop Conn 7205836/72-00153-0 S&N T.A.P. TUBING 72-00180-0 CONMED CPS TUBING 710424/72-00268-0 STERIS OLY INLINE ADPTR TUBING 710304/72-00311-0 STERIS COEFFICIENT TUBING SETS 710425/72-00281-0 STERIS PENTAX ADAPTER TUBING SET 710426/72-00280-0 STERIS FUJIFILM ADAPTER TUBING SET 72-00204-0 S&N IN LINE GAS WARMER, 72-00181-0 CONMED IN LINE GAS WARME 6-820-00 NORTECH IN LINE GAS WARMER Set, General Use with Suction Connector 4270 / 72-00146-0 S & N HIGH PRESSURE HOSE & YOKE 66-53030-0 CONMED GS1050 ADAPTER CP 7-510-09 NORTECH HIGH PRESSURE HOSE 7204275 / 72-00328 S&N METAL ADAPTER CPC-LU 66-53070 CONMED GS1051 ADAPTER CP 7-510-50 NTI SHUTTLE VALVE SYSTEM 72-00183-0 CONMED GS 1053 HOSE & DI 055 / 72-00147-0 S&N HIGH FLOW BARBED CONN DIST BY S&N 72203995 / 72-00273-0 S & N SHUTTLE VALVE SYSTEM 7-510-34 HOSE AND DISS CO2 7205972 / 72-00166-0 S&N DISS CONNECTOR AND HOSE 72-00182-0 CONMED GS 1052 HOSE & YO 72-00174-0 S & N HOSE & DIN ASSEMBL 7-510-60 Nebulae Smoke Evacuation Tubing Set 72-00259-0/72203994 Smith & Nephew 500 72-00258-0 ConMed GS2000 7-650-00 Nebulae I Extender Cable 9-004-00 Autolith Uro-Touch 9-203-00 Autolith Touch 250cm Probe 9-202-2501 Autolith Touch 375cm Probe 9-202-3751DS Autolith Uro-Touch 120cm Probe 9-203-1203 Autolith Touch 375cm Probe 9-202-3751 Autolith Touch M005466800 Autolith Touch 9-202-00 Extender Cable M00546750 Autolith Touch 1.9FR 375cm DS Probe M00546620 9-201-00 AUTOLITH GENERATOR (115V) 9-201-01 AUTOLITH GENERATOR (100V) 72-00235-0 EXTENDER CABLE 9-003-00 POWER CORD 9-002-00 CABLE EXTENDER 9-001-00 FOOTSWITCH 72-00234-0 PNEUMATIC FOOT SWITCH 72-00255-0/390308 Protocol Touch 7-650-50 Dual CO2 Cylinder Hose with Gauges 7-510-57 NEBULAE SRS CO2 Gas Filtration Tubing Set 7-700-00 NEBULAE SRS Laparoscopic Surgical Pump 9-203-0543 AUTOLITH URO-TOUCH 9 French Probe 54CM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2025-01-27
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2025-01-27
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2025-01-27
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2025-01-27
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2025-01-27
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-01-27
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2025-01-27
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2025-01-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-01-27
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2025-01-27
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2025-01-27
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2025-01-27
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2025-01-27
OSV	Insufflator, Endoscopic Vessel Harvesting	Obstetrics/Gynecology	Class 2	884.1730	2025-01-27
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2025-01-27
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2025-01-27
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2025-01-27
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2025-03-27
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2025-01-27
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2025-01-27

Official Correspondent

Jerry Briggs

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Northgate Technologies, 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
K981334	Richard Wolf Medical Instruments Corp.	LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)	1998-09-10
K833646	Edward Weck, Inc.	PULSATRON NERVE LOCATOR/STIMULATOR	1984-02-10
K150005	Ndi Medical, LLC	Checkpoint, Checkpoint Head & Neck	2015-02-19
K232314	FUJIFILM Healthcare Americas Corporation	Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)	2023-09-01
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

Similar Registrations

Registration Number	Establishment Name	Location
1057358	RG Medical USA	Mount Juliet, TN, US
1225798	ATC TECHNOLOGIES INC.	Wilmington, MA, US
9610612	AESCULAP AG	TUTTLINGEN, DONAU Baden-Wurttemberg, DE
1320894	CONMED CORPORATION	Utica, NY, US
3001556604	Novanta Medical GmbH	BERLIN, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1450997. Last updated year: 2026. Please use registration number 1450997 when referencing this establishment in official correspondence.