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Northgate Technologies Inc.

Last updated September 17, 2026

Information

Country: US
Address: 1591 Scottsdale Court, Elgin, IL, 60123
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1450997
DUNS Number: —

Catalogue (116)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Flo-Assist II	7-510-49	FDA UDI	Class II	Active
Lithotripsy Probe 1.9FR 375cm	9-202-3751	FDA UDI	Class II	Active
Lithotripsy Probe 1.9FR 375cm DS French	9-195-371DS-F	FDA UDI	Class II	Active
Autolith Touch	M0054668H0	FDA UDI	Class II	Active
Power Cord	9-003-00	FDA UDI	Class II	Active
CO2 Hose and DISS	7-510-34	FDA UDI	Class II	Active
Autolith Touch	M0054668L0	FDA UDI	Class II	Active
PUREPNEUMO Tubing Set	7-650-01	FDA UDI	Class I	Active
In-Line Gas Warmer	72-00204-0	FDA UDI	Class II	Active
Insufflation Tubing, Gen Use 15/22mm	7-510-46	FDA UDI	Class II	Active
Lithotripsy Probe 9FR 54cm	9-900-54	FDA UDI	Class II	Active
Extender Cable, Autolith Touch	M00546750	FDA UDI	Class II	Active
TAP Tubing Set	7-510-31	FDA UDI	Class II	Active
Autolith Touch	M0054668R0	FDA UDI	Class II	Active
Insufflation Tubing, Gen Use Barb Conn	7-510-32	FDA UDI	Class II	Active
Nebulae Smoke Evacuation Tubing Set	7-510-60	FDA UDI	Class II	Active
Lithotripsy Probe 1.9FR 375cm DS	9-195-371DS	FDA UDI	Class II	Active
Insufflation Tubing, Laparoscopic	7-510-52	FDA UDI	Class II	Active
Autolith Touch	M0054668D0	FDA UDI	Class II	Active
Tap	7205836	FDA UDI	Class II	Active
Lithotripsy Probe 9FR 54cm	9-203-0543	FDA UDI	Class II	Active
Autolith 100V	9-201-01	FDA UDI	Class II	Active
Lithotripsy Probe 1.9FR 375cm DS	9-202-3751DS	FDA UDI	Class II	Active
Autolith 115V	9-201-00	FDA UDI	Class II	Active
Lithotripsy Probe 1.9FR 250cm French	9-195-25-F	FDA UDI	Class II	Active
Connector, Barbed High Flow, Insufflation	8055	FDA UDI	Class II	Active
StimSite AM-VY1 Adapter	AM-VY1	FDA UDI	Class II	Active
CO2 Hose and Yoke	7-510-09	FDA UDI	Class II	Active
Autolith Touch	M0054668ZR0	FDA UDI	Class II	Active
Insufflation Tubing, Universal	7-510-16	FDA UDI	Class II	Active
Lithotripsy Probe 1.9FR 375cm	9-195-371	FDA UDI	Class II	Active
Nebulae I	7-650-00	FDA UDI	Class II	Active
CO2 Hose and DIN	7-510-36	FDA UDI	Class II	Active
StimSite Activation Card	AM-2101	FDA UDI	Class II	Active
Lithotripsy Probe 1.9FR 375cm French	9-195-371-F	FDA UDI	Class II	Active
NEBULAE SRS Laparoscopic Surgical Pump	7-700-00	FDA UDI	Class II	Active
Lithotripsy Probe 1.9FR 250cm	9-202-2501	FDA UDI	Class II	Active
Lithotripsy Probe 1.9FR 250cm	9-195-25	FDA UDI	Class II	Active
StimSite Signal Box	AM-101	FDA UDI	Class II	Active
Insufflation Tubing, Gen Use 15mm	7-510-15	FDA UDI	Class II	Active
NEBULAE SRS Tubing Set	7-510-57	FDA UDI	Class II	Active
Suction Tubing Set	72-00327-0	FDA UDI	Class II	Active
In-Line Gas Warmer	6-820-00	FDA UDI	Class II	Active
Footswitch	9-001-00	FDA UDI	Class II	Active
Autolith Uro-Touch	9-203-00	FDA UDI	Class II	Active
Dual CO2 Cylinder Hose	7-650-50	FDA UDI	Class I	Active
Insufflation Tubing, Gen Use CPC	7-510-28	FDA UDI	Class II	Active
In-Line Gas Warmer	6-810-00	FDA UDI	Class II	Active
Extender Cable, Autolith	9-002-00	FDA UDI	Class II	Active
Lithotripsy Probe 1.9FR 375cm DS	M00546620	FDA UDI	Class II	Active

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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.