FDA Registration
Active
🇺🇸 United States
Northgate Technologies Inc.
Reg #: 1450997
·
FEI: 1450997
·
Expires 2026
Products
14
Proprietary Names
70
Establishment Types
4
Classifications
14
Registration Details
- Registration Name
- Northgate Technologies Inc.
- Registration Number
- 1450997
- FEI Number
- 1450997
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1591 Scottsdale Court
- City
- Elgin
- State
- IL
- ZIP
- 60123
- Country
- US
Regulatory Submissions
- 510(k) Number
- K914403
Owner / Operator
- Firm Name
- Northgate Technologies, Inc.
- Operator Number
- 10092614
- Address
- 1591 Scottsdale Court
- City
- Elgin
- State
- IL
- Postal Code
- 60123
- Country
- US
- Correspondent
- Jerry Briggs
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2025-01-27 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2025-01-27 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2025-01-27 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2025-01-27 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2025-01-27 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | Class 2 | Gastroenterology, Urology | No | 2025-01-27 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2025-01-27 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2025-01-27 |
| Insufflator, Endoscopic Vessel Harvesting | OSV | Class 2 | Obstetrics/Gynecology | No | 2025-01-27 |
| Lithotriptor, Electro-Hydraulic | FFK | Class 2 | Gastroenterology, Urology | No | 2025-01-27 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2025-03-27 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2025-01-27 |
| Evacuator, Gastro-Urology | KQT | Class 2 | Gastroenterology, Urology | No | 2025-01-27 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2025-01-27 |
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
72-00327-0 SMOKE SUCTION TUBING WITH FILTER
7-510-44 NORTHGATE SUCTION TUBING
72-00162-0 OLYMPUS SUCTION TUBING
7-510-62 NTI Cart for NEBULAE I SYSTEM
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility