Northgate Technologies Inc.
Elgin, IL, US
Northgate Technologies Inc. appears in FDA device records in Elgin, IL. FDA records list 55 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 55FDA records hold 55 510(k) clearances for Northgate Technologies Inc. between 1991 and 2021. The busiest year on record is 1991, with 18. The most recent is 2021, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 18 |
| 1992 | 8 |
| 1993 | 2 |
| 1994 | 3 |
| 1995 | 2 |
| 1996 | 3 |
| 1997 | 3 |
| 1998 | 2 |
| 1999 | 3 |
| 2000 | 2 |
| 2001 | 2 |
| 2003 | 1 |
| 2004 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2021 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K202813 | URO-TOUCH 9 French Probe | FFK | Substantially Equivalent | |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | FYD | Substantially Equivalent | |
| K130368 | AUTOLITH TOUCH; URO TOUCH | FFK | Substantially Equivalent | |
| K120151 | NEBULAE I | HIF | Substantially Equivalent | |
| K041560 | FLO-ASSISTANT | HIF | Substantially Equivalent | |
| K033614 | MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 | HIF | Substantially Equivalent | |
| K022052 | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 | HIF | Substantially Equivalent | |
| K010053 | HUMI-FLOW, MODEL 6-850-00/ 01/02 | HIF | Substantially Equivalent | |
| K011928 | HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 | FPA | Substantially Equivalent | |
| K001325 | FLO ASSISTANT, MODEL 4-250-00 | LJH | Substantially Equivalent | |
| K993778 | HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 | OCX | Substantially Equivalent | |
| K992381 | CO2 GAS WARMER II, MODEL 6-800-00 | HIF | Substantially Equivalent | |
| K990341 | ELECTRO MECHANICAL LITHOTRIPTOR | FFK | Substantially Equivalent | |
| K983326 | OMNIFLATOR 7640 MODEL 7-640-00 | HIF | Substantially Equivalent | |
| K973447 | OMNIFLATOR 6630(6-630-00) | HIF | Substantially Equivalent | |
| K972675 | CO2 GAS WARMING UNIT (6-800-00) | HIF | Substantially Equivalent | |
| K973025 | FLUID CENTURION (4-100-00) | FLN | Substantially Equivalent | |
| K962271 | ELECTROSURGICAL ELECRTRODES | HIH | Substantially Equivalent | |
| K970717 | VAPOR-TECH SLED ELECTRODE | FAS | Substantially Equivalent | |
| K964196 | CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) | OCX | Substantially Equivalent | |
| K954710 | VAPOR-TECH ROLLER BALL ELECTRODE 24 FR. | FAS | Substantially Equivalent | |
| K955339 | HYDROLOGY 5000 | GBX | Substantially Equivalent | |
| K943361 | NORTHGATE FLOW ASSIST TUBING FOR UROLOGY | LJH | Substantially Equivalent | |
| K944571 | PULSE GUARD 3FR ELECTRODE | FFK | Substantially Equivalent | |
| K931065 | LAPAROVIEW | HET | Substantially Equivalent | |
| K930912 | HYSTEROMED 100 | HIG | Substantially Equivalent | |
| K935862 | NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600 | HIF | Substantially Equivalent | |
| K925396 | PULSE GUARD ELECTRODE | FFK | Substantially Equivalent | |
| K923822 | AUTOLITH-IEHL | FFK | Substantially Equivalent | |
| K921451 | EVACUATOR, GASTRO-UROLOGY | KQT | Substantially Equivalent | |
| K921088 | EVACUATOR, GASTRO-UROLOGY | KQT | Substantially Equivalent | |
| K914517 | SD-200IEHL(TM) | FFK | Substantially Equivalent | |
| K915051 | MODIFICATION MODEL 7201 INSUFFLATOR | HIF | Substantially Equivalent | |
| K914861 | EVACUATION KIT #7-510-14 | GCJ | Substantially Equivalent | |
| K914516 | 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | FFK | Substantially Equivalent | |
| K914515 | 3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | FFK | Substantially Equivalent | |
| K914514 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | FFK | Substantially Equivalent | |
| K913955 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | FFK | Substantially Equivalent | |
| K914403 | GENERAL USE KIT #7-510-20 | HIF | Substantially Equivalent | |
| K914402 | RECIRCULATION KIT #7-510-18 | HIF | Substantially Equivalent | |
| K914401 | UNIVERSAL GENERAL USE KIT #7-510-16 | HIF | Substantially Equivalent | |
| K911179 | VERRES NEEDLES 5 & 6 INCHES | HIF | Substantially Equivalent | |
| K913992 | ASPIRATION/INJECTION NEEDLE | GAA | Substantially Equivalent | |
| K911364 | SPOON FORCEPS, 11MM | LQC | Substantially Equivalent | |
| K913991 | GRASPER, RATCHETED (5MM X 30CM) | GCJ | Substantially Equivalent | |
| K911312 | SUCTION/IRRIGATION TUBE & TUBE WITH CHANNEL | GEI | Substantially Equivalent | |
| K911243 | CHOLANGIOCATH AND ATRAUMATIC BOWEL CLAMP | GCJ | Substantially Equivalent | |
| K911365 | ELECTROCAUTERY CABLE, BOVIE(TM)/BANANA PLUGS | GEI | Substantially Equivalent | |
| K911316 | INSULATED HOOK SCISSORS/J & L HOOK KNIVES/SPATULA | GEI | Substantially Equivalent | |
| K911157 | APPLICATOR LOOP SUTURES | GCJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1450997 | 1450997 | Northgate Technologies Inc. | 1591 Scottsdale Court, Elgin, IL 60123 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FYDApparatus, Exhaust, Surgical
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- GBXCatheter, Irrigation
- FASElectrode, Electrosurgical, Active, Urological
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- OCXEndoscopic Irrigation/Suction System
- KQTEvacuator, Gastro-Urology
- HTDForceps
- GENForceps, General & Plastic Surgery
- FDSGastroscope And Accessories, Flexible/Rigid
- HIHHysteroscope (And Accessories)
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- OSVInsufflator, Endoscopic Vessel Harvesting
- HIGInsufflator, Hysteroscopic
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- GCILaryngoscope, Endoscope
- LQCLithotriptor, Biliary Mechanical
- FFKLithotriptor, Electro-Hydraulic
- FLNMonitor, Electric For Gravity Flow Infusion Systems
- GAANeedle, Aspiration And Injection, Disposable
- LRWScissors, General, Surgical
- FPASet, Administration, Intravascular
- FOXStand, Infusion
- ETNStimulator, Nerve
- LJHSystem, Irrigation, Urological
- GAZTubing, Noninvasive
- BYXTubing, Pressure And Accessories
- NKCTubing/Tubing With Filter, Insufflation, Laparoscopic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1235-2022 | AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe | Product labeled incorrectly. | Class II | Terminated | |
| Z-0333-2022 | Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi. | The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device. | Class II | Open, Classified | |
| Z-1148-2021 | Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. | An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. | Class II | Terminated | |
| Z-1147-2021 | ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery). | An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. | Class II | Terminated | |
| Z-1885-2020 | ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi. | Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. | Class II | Terminated | |
| Z-1884-2020 | AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi. | Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. | Class II | Terminated | |
| Z-1883-2020 | Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi. | As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. | Class II | Terminated | |
| Z-0073-2018 | Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically. | The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. Could Delay Care. | Class II | Terminated | |
| Z-0866-2017 | Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures | Device could cause a patient overpressure situation without any visual or auditory indication or warning | Class II | Terminated | |
| Z-3179-2011 | Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per box; Manufactured for: Olympus America Inc., Two Corporate Center Drive, Melville, NY 11747-3157; catalog #72-00114-0 The fluid aspiration set is used in conjunction with the Olympus SP-2 pump for fluid aspiration during urological endoscopic procedures or laparoscopic procedures. | The Red Tag was assembled to the wrong end of the silicone tubing. The Red Tag indicates how the fluid aspiration tubing set is loaded into the Olympus SP-2 Fluid Irrigation and Aspiration Pump. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain