Data / Medical devices / United States / Northgate Technologies Inc.
Northgate Technologies Inc.: FDA-registered device maker in Elgin, IL, United States, 14 510(k) clearances
Northgate Technologies Inc. is registered with the FDA (registration 1450997) in Elgin, IL, United States. It lists 14 device types. The FDA files 14 510(k) clearances under its listings, the newest dated June 14, 2021. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1450997
- Address
- 1591 Scottsdale Court, Elgin, IL, United States, 60123
- Owner or operator
- Northgate Technologies, Inc. (10092614)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 27, 2025
- Registered through
- 2026
- Brand names listed
- 055 / 72-00147-0 S&N HIGH FLOW BARBED CONN DIST BY S&N, 4270 / 72-00146-0 S & N HIGH PRESSURE HOSE & YOKE, 6-820-00 NORTECH IN LINE GAS WARMER, 66-53030-0 CONMED GS1050 ADAPTER CP, 66-53070 CONMED GS1051 ADAPTER CP, 7-510-09 NORTECH HIGH PRESSURE HOSE, 7-510-15 GENERAL USE 15mm CONN, 7-510-16 UNIVERSAL TUBING SET and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 14, 2021 | K202813 | URO-TOUCH 9 French Probe | FFK | Substantially Equivalent | Northgate Technologies, Inc. | accessdata.fda.gov |
| March 25, 2021 | K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | FYD | Substantially Equivalent | Northgate Technologies, Inc. | accessdata.fda.gov |
| November 10, 2020 | K200886 | StimSite | ETN | Substantially Equivalent | Allotrope Medical, Inc. | accessdata.fda.gov |
| February 14, 2014 | K132192 | BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR | FCX | Substantially Equivalent | Bracco Diagnostic, Inc. | accessdata.fda.gov |
| November 15, 2013 | K130368 | AUTOLITH TOUCH; URO TOUCH | FFK | Substantially Equivalent | Northgate Technologies, Inc. | accessdata.fda.gov |
| August 6, 2013 | K123047 | BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET | FCX | Substantially Equivalent | Bracco Diagnostic, Inc. | accessdata.fda.gov |
| August 17, 2012 | K120151 | NEBULAE I | HIF | Substantially Equivalent | Northgate Technologies, Inc. | accessdata.fda.gov |
| January 24, 2003 | K022052 | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 | HIF | Substantially Equivalent | Northgate Technologies, Inc. | accessdata.fda.gov |
| February 5, 1999 | K983326 | OMNIFLATOR 7640 MODEL 7-640-00 | HIF | Substantially Equivalent | Northgate Technologies, Inc. | accessdata.fda.gov |
| September 30, 1998 | K972675 | CO2 GAS WARMING UNIT (6-800-00) | HIF | Substantially Equivalent | Northgate Technologies, Inc. | accessdata.fda.gov |
| January 28, 1993 | K923822 | AUTOLITH-IEHL | FFK | Substantially Equivalent | Northgate Technologies, Inc. | accessdata.fda.gov |
| October 28, 1992 | K921451 | EVACUATOR, GASTRO-UROLOGY | KQT | Substantially Equivalent | Northgate Technologies, Inc. | accessdata.fda.gov |
| January 27, 1992 | K914861 | EVACUATION KIT #7-510-14 | GCJ | Substantially Equivalent | Northgate Technologies, Inc. | accessdata.fda.gov |
| November 27, 1991 | K914403 | GENERAL USE KIT #7-510-20 | HIF | Substantially Equivalent | Northgate Technologies, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 13, 2022 | 90095 | Class II | Terminated | AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe | Product labeled incorrectly. | accessdata.fda.gov |
| October 25, 2021 | 88944 | Class II | Ongoing | 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. | accessdata.fda.gov |
| January 15, 2021 | 87231 | Class II | Terminated | 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 | An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. | accessdata.fda.gov |
| March 10, 2020 | 85204 | Class II | Terminated | 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. | accessdata.fda.gov |
| May 24, 2017 | 77367 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| November 21, 2016 | 75716 | Class II | Terminated | 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 insu | Device could cause a patient overpressure situation without any visual or auditory indication or warning | accessdata.fda.gov |
| July 25, 2011 | 59656 | Not yet classified | Terminated | 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 Cente | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Lithotriptor, Electro-Hydraulic
- All makers of Evacuator, Gastro-Urology
- All makers of Insufflator, Laparoscopic
- All makers of Insufflator, Automatic Carbon-Dioxide For Endoscope
- All makers of Gastroscope And Accessories, Flexible/Rigid
- All makers of Stimulator, Nerve
Updated June 14, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.