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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 2 of 3

Device	Model / Reference	Registries	Class	Status
Autolith Touch	M005466800	FDA UDI	Class II	Active
CO2 Hose and Yoke Shuttle Valve System	7-510-50	FDA UDI	Class II	Active
Autolith Touch	9-202-00	FDA UDI	Class II	Active
Foot Switch, Autolith Touch	M00546760	FDA UDI	Class II	Active
Smith & Nephew Insufflator 500	72203994	FDA UDI	Class II	Active
Smith & Nephew Insufflator 500	72203994S	FDA UDI	Class II	Active
Lithotripsy Probe 1.9FR 120cm	9-203-1203	FDA UDI	Class II	Active
Adapter for Hoses	7204275	FDA UDI	Class II	Active
Power Cord, Autolith Touch, North America	M00546770	FDA UDI	Class II	Active
Lithotripsy Probe 1.9FR 120cm	9-196-12	FDA UDI	Class II	Active
Extender Cable, Autolith Touch/Uro-Touch	9-004-00	FDA UDI	Class II	Active
Suction Tubing Set	7-510-44	FDA UDI	Class II	Active
Humi-Flow, Model 6-850-00/ 01/02	K010053	FDA 510(k)	Class II	Active
Autolith-Iehl	K923822	FDA 510(k)	Class II	Active
Hydrotower Arthroscopic Administration Tubing Set, Model 7-460-05	K011928	FDA 510(k)	Class II	Active
NEBULAE SRS Laparoscopic Surgical Smoke Removal System	K202944	FDA 510(k)	Class II	Active
Sd-200iehl(tm)	K914517	FDA 510(k)	Class II	Active
Flo Assistant, Model 4-250-00	K001325	FDA 510(k)	Class II	Active
General Use Kit #7-510-20	K914403	FDA 510(k)	Class II	Active
Spoon Forceps, 11mm	K911364	FDA 510(k)	Class II	Active
Palpation Probe	K911159	FDA 510(k)	Class I	Active
Omniflator 6630(6-630-00)	K973447	FDA 510(k)	Class II	Active
Laparoview	K931065	FDA 510(k)	Class II	Active
Electrocautery Cable, Bovie(tm)/Banana Plugs	K911365	FDA 510(k)	Class II	Active
Northgate Flow Assist Tubing For Urology	K943361	FDA 510(k)	Class II	Active
Evacuation Kit #7-510-14	K914861	FDA 510(k)	Class II	Active
Fluid Centurion (4-100-00)	K973025	FDA 510(k)	Class II	Active
Grasper, Ratcheted (5mm X 30cm)	K913991	FDA 510(k)	Class II	Active
Northgate Technologies Model 7201 Insufflator	K905481	FDA 510(k)	Class II	Active
Cholangiocath And Atraumatic Bowel Clamp	K911243	FDA 510(k)	Class II	Active
Evacuator, Gastro-Urology	K921088	FDA 510(k)	Class II	Active
Endoscope And Accessories	K905117	FDA 510(k)	Class II	Active
Nebulae I	K120151	FDA 510(k)	Class II	Active
Co2 Gas Warmer Ii, Model 6-800-00	K992381	FDA 510(k)	Class II	Active
Vapor-Tech Sled Electrode	K970717	FDA 510(k)	Class II	Active
Omniflator 7640 Model 7-640-00	K983326	FDA 510(k)	Class II	Active
Insulated Hook Scissors/J & L Hook Knives/Spatula	K911316	FDA 510(k)	Class II	Active
Verres Needles 5 & 6 Inches	K911179	FDA 510(k)	Class II	Active
Aspiration/Injection Needle	K913992	FDA 510(k)	Class I	Active
1.9 French Lithotripter Electrode, Modification	K913955	FDA 510(k)	Class II	Active
9 French Lithotripter Electrode, Modification	K914516	FDA 510(k)	Class II	Active
Modification Model 7201 Insufflator	K915051	FDA 510(k)	Class II	Active
Evacuator, Gastro-Urology	K921451	FDA 510(k)	Class II	Active
Autolith Touch; Uro Touch	K130368	FDA 510(k)	Class II	Active
3 French Lithotripter Electrode, Modification	K914515	FDA 510(k)	Class II	Active
Electro Mechanical Lithotriptor	K990341	FDA 510(k)	Class II	Active
Hydrology 5000	K955339	FDA 510(k)	Class I	Active
Recirculation Kit #7-510-18	K914402	FDA 510(k)	Class II	Active
Universal General Use Kit #7-510-16	K914401	FDA 510(k)	Class II	Active
Hydrotower Management System, Model 4-750-00	K993778	FDA 510(k)	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.