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Sign in to claim this brandNorthgate Technologies Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1591 Scottsdale Court, Elgin, IL, 60123
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1450997
- DUNS Number
- —
Catalogue (116)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Northgate Technologies Omniflator Model 6600 | K935862 | FDA 510(k) | Class II | Active |
| 40lpm Abdominal Insufflator, Catalog # 72-00203-0 | K022052 | FDA 510(k) | Class II | Active |
| Continuous Flow System, Cfs-1 Pump System (4-700-00) | K964196 | FDA 510(k) | Class II | Active |
| URO-TOUCH 9 French Probe | K202813 | FDA 510(k) | Class II | Active |
| Co2 Gas Warming Unit (6-800-00) | K972675 | FDA 510(k) | Class II | Active |
| Pulse Guard 3fr Electrode | K944571 | FDA 510(k) | Class II | Active |
| Flo-Assistant | K041560 | FDA 510(k) | Class II | Active |
| Hysteromed 100 | K930912 | FDA 510(k) | Class II | Active |
| Mistic Humidification System 850-00/01/02, 2215 | K033614 | FDA 510(k) | Class II | Active |
| Vapor-Tech Roller Ball Electrode 24 Fr. | K954710 | FDA 510(k) | Class II | Active |
| Suction/Irrigation Tube & Tube With Channel | K911312 | FDA 510(k) | Class II | Active |
| Electrosurgical Elecrtrodes | K962271 | FDA 510(k) | Class II | Active |
| Claw (5mm/10mm) Atraumatic Grasp/Micro Forceps | K911180 | FDA 510(k) | Class I | Active |
| Applicator Loop Sutures | K911157 | FDA 510(k) | Class II | Active |
| Pulse Guard Electrode | K925396 | FDA 510(k) | Class II | Active |
| 1.9 French Lithotripter Electrode, Modification | K914514 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (10)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 13, 2022 | Z-1235-2022 | — | terminated | Product labeled incorrectly. |
| Oct 25, 2021 | Z-0333-2022 | — | open, classified | The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device. |
| Jan 15, 2021 | Z-1147-2021 | — | terminated | An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. |
| Jan 15, 2021 | Z-1148-2021 | — | terminated | An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. |
| Mar 10, 2020 | Z-1883-2020 | — | terminated | As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. |
| Mar 10, 2020 | Z-1884-2020 | — | terminated | Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. |
| Mar 10, 2020 | Z-1885-2020 | — | terminated | Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. |
| May 24, 2017 | Z-0073-2018 | — | terminated | 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. |
| Nov 21, 2016 | Z-0866-2017 | — | terminated | Device could cause a patient overpressure situation without any visual or auditory indication or warning |
| Jul 25, 2011 | Z-3179-2011 | — | terminated | 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. |