NEBULAE SRS Laparoscopic Surgical Smoke Removal System
Northgate Technologies Inc.
Northgate Technologies Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1450997 | 1450997 | Northgate Technologies Inc. | 1 | N | 2026-01-01 | 1591 Scottsdale Court Elgin IL US 60123 |
| 1450997 | 1450997 | Northgate Technologies Inc. | 1 | N | 2020-04-25 | 1591 Scottsdale Court Elgin IL US 60123 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 76901 | 1228169798 | K993778 | HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 | OCX | 2000-01-06 |
| 76901 | 1304715282 | K992381 | CO2 GAS WARMER II, MODEL 6-800-00 | HIF | 1999-09-17 |
| 336592 | 1005814553 | K983326 | OMNIFLATOR 7640 MODEL 7-640-00 | HIF | 1999-02-05 |
| 76901 | 2042398944 | K983326 | OMNIFLATOR 7640 MODEL 7-640-00 | HIF | 1999-02-05 |
| 76901 | 1750091653 | K973447 | OMNIFLATOR 6630(6-630-00) | HIF | 1998-09-30 |
| 76901 | 1421875336 | K972675 | CO2 GAS WARMING UNIT (6-800-00) | HIF | 1998-09-30 |
| 336592 | 1687419720 | K972675 | CO2 GAS WARMING UNIT (6-800-00) | HIF | 1998-09-30 |
| 76901 | 1754427001 | K943361 | NORTHGATE FLOW ASSIST TUBING FOR UROLOGY | LJH | 1995-09-29 |
| 76901 | 1969618893 | K935862 | NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600 | HIF | 1994-08-19 |
| 76901 | 1392384722 | K931606 | 7-510-25 HYSTEROMED TUBING KIT | HIG | 1994-01-24 |
| 76901 | 1455277438 | K930912 | HYSTEROMED 100 | HIG | 1994-10-17 |
| 76901 | 1736757334 | K925396 | PULSE GUARD ELECTRODE | FFK | 1993-07-30 |
| 76901 | 1934604459 | K923822 | AUTOLITH-IEHL | FFK | 1993-01-28 |
| 336592 | 1949377086 | K923822 | AUTOLITH-IEHL | FFK | 1993-01-28 |
| 76901 | 1345940939 | K921451 | EVACUATOR, GASTRO-UROLOGY | KQT | 1992-10-28 |
| 336592 | 1491766023 | K921451 | EVACUATOR, GASTRO-UROLOGY | KQT | 1992-10-28 |
| 76901 | 2028307200 | K915051 | MODIFICATION MODEL 7201 INSUFFLATOR | HIF | 1992-06-04 |
| 336592 | 1362779913 | K914861 | EVACUATION KIT #7-510-14 | GCJ | 1992-01-27 |
| 76901 | 1666555470 | K914861 | EVACUATION KIT #7-510-14 | GCJ | 1992-01-27 |
| 76901 | 1716810015 | K914516 | 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | FFK | 1992-01-07 |
| 76901 | 1889695788 | K914515 | 3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | FFK | 1992-01-07 |
| 76901 | 2018458230 | K914514 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | FFK | 1992-01-06 |
| 336592 | 1394371847 | K914403 | GENERAL USE KIT #7-510-20 | HIF | 1991-11-27 |
| 76901 | 1900433578 | K914403 | GENERAL USE KIT #7-510-20 | HIF | 1991-11-27 |
| 76901 | 2064133318 | K914401 | UNIVERSAL GENERAL USE KIT #7-510-16 | HIF | 1991-11-27 |
| 76901 | 1450714432 | K852874 | 5F ELECTRODE(LITHOTRIPTOR) | FFK | 1985-08-21 |
| 76901 | 1253973976 | K802322 | MODEL SD-1 DISINTEGRATOR | FFK | 1980-11-10 |
| 336592 | 1104556386 | K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | FYD | 2021-03-25 |
| 336592 | 1029495343 | K202813 | URO-TOUCH 9 French Probe | FFK | 2021-06-14 |
| 336592 | 1180860861 | K200886 | StimSite | ETN | 2020-11-10 |
| 76901 | 1527570556 | K132192 | BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR | FCX | 2014-02-14 |
| 336592 | 1605291823 | K132192 | BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR | FCX | 2014-02-14 |
| 76901 | 1407170940 | K130368 | AUTOLITH TOUCH; URO TOUCH | FFK | 2013-11-15 |
| 336592 | 1510777065 | K130368 | AUTOLITH TOUCH; URO TOUCH | FFK | 2013-11-15 |
| 336592 | 1388300908 | K123047 | BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET | FCX | 2013-08-06 |
| 76901 | 1476237833 | K120151 | NEBULAE I | HIF | 2012-08-17 |
| 336592 | 1695675105 | K120151 | NEBULAE I | HIF | 2012-08-17 |
| 76901 | 1377463421 | K111648 | BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR | FCX | 2011-11-03 |
| 76901 | 1929877102 | K053008 | E-Z-EM ENDOSCOPIC CO2 REGULATOR | FCX | 2005-12-27 |
| 76901 | 1143140612 | K041560 | FLO-ASSISTANT | HIF | 2004-09-28 |
| 76901 | 1963096611 | K033614 | MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 | HIF | 2004-07-29 |
| 76901 | 1832973864 | K030854 | PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 | FCX | 2003-04-16 |
| 76901 | 1669895088 | K022052 | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 | HIF | 2003-01-24 |
| 336592 | 1710618632 | K022052 | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 | HIF | 2003-01-24 |
| 76901 | 1584253481 | K011928 | HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 | FPA | 2001-08-10 |
| 76901 | 1533178885 | K010053 | HUMI-FLOW, MODEL 6-850-00/ 01/02 | HIF | 2001-10-23 |
| 76901 | 1223404592 | K001325 | FLO ASSISTANT, MODEL 4-250-00 | LJH | 2000-08-18 |
| 76901 | 1113736011 | ||||
| 76901 | 1679816462 | ||||
| 336592 | 1050667054 | ||||
| 336592 | 1064880134 | ||||
| 336592 | 1570521268 | ||||
| 336592 | 1918809384 | ||||
| 336592 | 2056596089 |
Product Codes Associated With Registrations#
PMN#
AUTOLITH TOUCH; URO TOUCH
NORTHGATE TECHNOLOGIES INC.
NEBULAE I
NORTHGATE TECHNOLOGIES INC.
GUDID#
Dual CO2 Cylinder Hose - Dual CO2 Cylinder Hose with Gauges
2025-03-31
Dual CO2 Cylinder Hose - Dual CO2 Cylinder Hose with Gauges
2025-03-31
StimSite AM-VY1 Adapter - StimSite Voyant Adapter
2024-07-10
PUREPNEUMO Tubing Set - Paired Insufflation and TAP Tubing
2024-07-09
PUREPNEUMO Tubing Set - Paired Insufflation and TAP Tubing
2024-07-09
StimSite Signal Box - AM-101
2024-04-29
Suction Tubing Set - 7-510-44
2019-02-22
Suction Tubing Set - Suction Tubing Set with Filter
2019-06-19
StimSite Activation Card - Activation Card, StimSite, Single
2023-11-21
NEBULAE SRS Tubing Set - 7-510-57
2023-02-14
NEBULAE SRS Laparoscopic Surgical Pump - 7-700-00
2023-02-14
N/A - CO2 Shuttle Valve System, Insufflation
2021-01-05
N/A - CO2 Hose and DISS, Insufflation
2021-01-05
N/A - CO2 Hose and Yoke, Insufflation
2021-01-05
CO2 Hose and Yoke - CO2 Hose and Yoke for use with Laparoscopic insufflators
2016-10-13
CO2 Hose and Yoke Shuttle Valve System - CO2 Hose and Yoke Shuttle Valve System is for use with Laparoscopic insufflators for hook up to two CO2 tanks.
2016-10-13
CO2 Hose and DISS - For use with laparoscopic insufflator for connection to wall source CO2.
2016-10-14
CO2 Hose and DIN - CO2 Hose and DIN for use with Laparoscopic insufflators
2016-10-14
Insufflation Tubing, Laparoscopic - Insufflation general use tubing set for use with the Nebulae I laparoscopic insufflator
2016-10-13
Insufflation Tubing, Gen Use 15mm - Insufflation Tubing for use with Laparoscopic Insufflators with 15mm connection
2016-10-14
Insufflation Tubing, Universal - Insufflation tubing for use with Laparoscopic Insufflators
2016-10-14
Insufflation Tubing, Gen Use CPC - Insufflation Tubing for use with Laparoscopic Insufflators
2016-10-14
Insufflation Tubing, Gen Use Barb Conn - Insufflation Tubing for use with Laparoscopic Insufflators
2016-10-14
Insufflation Tubing, Gen Use 15/22mm - Insufflation Tubing for use with Laparoscopic Insufflators with a 15 or 22mm connection
2016-10-14
TAP Tubing Set - True Abdominal Pressure Tubing Set for use with Laparoscopic Insufflators with TAP feature.
2016-10-14
TAP - Insufflation Tubing, True Abdominal Pressure Sensing
2021-01-05
N/A - Insufflation Tubing, General Use CPC
2021-01-05
Adapter for Hoses - 7204275
2020-08-07
Connector, Barbed High Flow, Insufflation - 8055
2020-08-07
Smith & Nephew Insufflator 500 - Insufflator, Laparoscopic, S&N 500 Service Replacement, 50LPM
2021-01-06
TAP - Insufflation Tubing, True Abdominal Pressure Sensing
2021-01-05
Smith & Nephew Insufflator 500 - Insufflator, Laparoscopic, 50LPM
2020-08-06
Nebulae Smoke Evacuation Tubing Set - This tubing set is used to evacuate surgical smoke using a wall vacuum source.
2019-06-19
Suction Tubing Set - Suction Tubing Set with Filter
2019-06-19
Nebulae Smoke Evacuation Tubing Set - This tubing set is used to evacuate surgical smoke using a wall vacuum source.
2019-06-19
Flo-Assist II - Irrigation Tubing Set
2016-10-14
Flo-Assist II - Irrigation Tubing Set
2016-10-14
Suction Tubing Set - 7-510-44
2019-02-22
In-Line Gas Warmer - In-Line gas warmer is for use with laparoscopic insufflators
2019-02-22
Lithotripsy Probe 1.9FR 120cm - 1.9FR 120cm Lithotripsy Probe for use with Autolith Lithotripters
2016-10-13