Company ยท US
Northgate Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2021. Name variants (Inc, Corp, punctuation) are merged.
55510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HIF | Insufflator, Laparoscopic | 18 |
| FFK | Lithotriptor, Electro-Hydraulic | 17 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 |
| KQT | Evacuator, Gastro-Urology | 3 |
| FAS | Electrode, Electrosurgical, Active, Urological | 2 |
| LJH | System, Irrigation, Urological | 2 |
| OCX | Endoscopic Irrigation/Suction System | 2 |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 1 |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| FYD | Apparatus, Exhaust, Surgical | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 |
| GBX | Catheter, Irrigation | 1 |
| GCI | Laryngoscope, Endoscope | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 |
| HIG | Insufflator, Hysteroscopic | 1 |
| HIH | Hysteroscope (And Accessories) | 1 |
| HTD | Forceps | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 14, 2021 | K202813 | URO-TOUCH 9 French Probe Northgate Technologies, Inc. | FFK |
| Mar 25, 2021 | K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System Northgate Technologies, Inc. | FYD |
| Nov 15, 2013 | K130368 | AUTOLITH TOUCH; URO TOUCH Northgate Technologies, Inc. | FFK |
| Aug 17, 2012 | K120151 | NEBULAE I Northgate Technologies, Inc. | HIF |
| Sep 28, 2004 | K041560 | FLO-ASSISTANT Northgate Technologies, Inc. | HIF |
| Jul 29, 2004 | K033614 | MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 Northgate Technologies, Inc. | HIF |
| Jan 24, 2003 | K022052 | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 Northgate Technologies, Inc. | HIF |
| Oct 23, 2001 | K010053 | HUMI-FLOW, MODEL 6-850-00/ 01/02 Northgate Technologies, Inc. | HIF |
| Aug 10, 2001 | K011928 | HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 Northgate Technologies, Inc. | FPA |
| Aug 18, 2000 | K001325 | FLO ASSISTANT, MODEL 4-250-00 Northgate Technologies, Inc. | LJH |
| Jan 6, 2000 | K993778 | HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 Northgate Technologies, Inc. | OCX |
| Sep 17, 1999 | K992381 | CO2 GAS WARMER II, MODEL 6-800-00 Northgate Technologies, Inc. | HIF |
| Jul 14, 1999 | K990341 | ELECTRO MECHANICAL LITHOTRIPTOR Northgate Technologies, Inc. | FFK |
| Feb 5, 1999 | K983326 | OMNIFLATOR 7640 MODEL 7-640-00 Northgate Technologies, Inc. | HIF |
| Sep 30, 1998 | K973447 | OMNIFLATOR 6630(6-630-00) Northgate Technologies, Inc. | HIF |
| Sep 30, 1998 | K972675 | CO2 GAS WARMING UNIT (6-800-00) Northgate Technologies, Inc. | HIF |
| Nov 20, 1997 | K973025 | FLUID CENTURION (4-100-00) Northgate Technologies, Inc. | FLN |
| Aug 8, 1997 | K962271 | ELECTROSURGICAL ELECRTRODES Northgate Technologies, Inc. | HIH |
| May 8, 1997 | K970717 | VAPOR-TECH SLED ELECTRODE Northgate Technologies, Inc. | FAS |
| Dec 23, 1996 | K964196 | CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) Northgate Technologies, Inc. | OCX |
| Apr 24, 1996 | K954710 | VAPOR-TECH ROLLER BALL ELECTRODE 24 FR. Northgate Technologies, Inc. | FAS |
| Mar 13, 1996 | K955339 | HYDROLOGY 5000 Northgate Technologies, Inc. | GBX |
| Sep 29, 1995 | K943361 | NORTHGATE FLOW ASSIST TUBING FOR UROLOGY Northgate Technologies, Inc. | LJH |
| Mar 17, 1995 | K944571 | PULSE GUARD 3FR ELECTRODE Northgate Technologies, Inc. | FFK |
| Nov 30, 1994 | K931065 | LAPAROVIEW Northgate Technologies, Inc. | HET |
| Oct 17, 1994 | K930912 | HYSTEROMED 100 Northgate Technologies, Inc. | HIG |
| Aug 19, 1994 | K935862 | NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600 Northgate Technologies, Inc. | HIF |
| Jul 30, 1993 | K925396 | PULSE GUARD ELECTRODE Northgate Technologies, Inc. | FFK |
| Jan 28, 1993 | K923822 | AUTOLITH-IEHL Northgate Technologies, Inc. | FFK |
| Oct 28, 1992 | K921451 | EVACUATOR, GASTRO-UROLOGY Northgate Technologies, Inc. | KQT |
| Oct 28, 1992 | K921088 | EVACUATOR, GASTRO-UROLOGY Northgate Technologies, Inc. | KQT |
| Jun 30, 1992 | K914517 | SD-200IEHL(TM) Northgate Technologies, Inc. | FFK |
| Jun 4, 1992 | K915051 | MODIFICATION MODEL 7201 INSUFFLATOR Northgate Technologies, Inc. | HIF |
| Jan 27, 1992 | K914861 | EVACUATION KIT #7-510-14 Northgate Technologies, Inc. | GCJ |
| Jan 7, 1992 | K914516 | 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION Northgate Technologies, Inc. | FFK |
| Jan 7, 1992 | K914515 | 3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION Northgate Technologies, Inc. | FFK |
| Jan 6, 1992 | K914514 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION Northgate Technologies, Inc. | FFK |
| Nov 29, 1991 | K913955 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION Northgate Technologies, Inc. | FFK |
| Nov 27, 1991 | K914403 | GENERAL USE KIT #7-510-20 Northgate Technologies, Inc. | HIF |
| Nov 27, 1991 | K914402 | RECIRCULATION KIT #7-510-18 Northgate Technologies, Inc. | HIF |
| Nov 27, 1991 | K914401 | UNIVERSAL GENERAL USE KIT #7-510-16 Northgate Technologies, Inc. | HIF |
| Nov 13, 1991 | K911179 | VERRES NEEDLES 5 & 6 INCHES Northgate Technologies, Inc. | HIF |
| Oct 30, 1991 | K913992 | ASPIRATION/INJECTION NEEDLE Northgate Technologies, Inc. | GAA |
| Oct 23, 1991 | K911364 | SPOON FORCEPS, 11MM Northgate Technologies, Inc. | LQC |
| Oct 4, 1991 | K913991 | GRASPER, RATCHETED (5MM X 30CM) Northgate Technologies, Inc. | GCJ |
| Sep 19, 1991 | K911312 | SUCTION/IRRIGATION TUBE & TUBE WITH CHANNEL Northgate Technologies, Inc. | GEI |
| Jun 19, 1991 | K911243 | CHOLANGIOCATH AND ATRAUMATIC BOWEL CLAMP Northgate Technologies, Inc. | GCJ |
| Jun 11, 1991 | K911365 | ELECTROCAUTERY CABLE, BOVIE(TM)/BANANA PLUGS Northgate Technologies, Inc. | GEI |
| Apr 29, 1991 | K911316 | INSULATED HOOK SCISSORS/J & L HOOK KNIVES/SPATULA Northgate Technologies, Inc. | GEI |
| Apr 25, 1991 | K911157 | APPLICATOR LOOP SUTURES Northgate Technologies, Inc. | GCJ |
Newest 50 of 55.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2022 | Northgate Technologies, Inc. AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe Terminated |
FFK | K130368 |
| Oct 25, 2021 | Northgate Technologies, Inc. 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 fragme Open, Classified |
FFK | K130368 |
| Jan 15, 2021 | Northgate Technologies, Inc. Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with Terminated |
FCX | K111648 |
| Jan 15, 2021 | Northgate Technologies, Inc. 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 ins Terminated |
HIF | K120151 |
| Mar 24, 2020 | Northgate Technologies, Inc. ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary Terminated |
FFK | K914516 |
| Mar 24, 2020 | Northgate Technologies, Inc. AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi. Terminated |
FFK | K130368 |
| Mar 24, 2020 | Northgate Technologies, Inc. Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi. Terminated |
FFK | K130368 |
| May 24, 2017 | Northgate Technologies, Inc. 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 fr Terminated |
FFK | K914514 |
| Nov 21, 2016 | Northgate Technologies, Inc. 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 operati Terminated |
HIF | K120151 |
| Sep 9, 2011 | Northgate Technologies, Inc. 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., Terminated |
KQT | K921451 |