Medical Device Manufacturer · US , Arlington Heights , IL

Northgate Technologies, Inc.

55 submissions · 55 cleared · Since 1991
55
Total
55
Cleared
0
Denied

Northgate Technologies, Inc. — FDA 510(k) Submissions

Northgate Technologies, Inc. has submitted 55 FDA 510(k) premarket notifications since 1991, of which 55 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Insufflator, Laparoscopic, Lithotriptor, Electro-hydraulic, Laparoscope, General & Plastic Surgery, Electrosurgical, Cutting & Coagulation & Accessories, Evacuator, Gastro-urology . Use the specialty filter in the sidebar to narrow results.

55 devices
1–25 of 55
URO-TOUCH 9 French Probe
K202813 · FFK Lithotriptor,... · Gastroenterology & Urology
Jun 2021 263d
NEBULAE SRS Laparoscopic Surgical Smoke Removal System
K202944 · FYD Apparatus, Exhaust, Surgical · General Hospital
Mar 2021 176d
AUTOLITH TOUCH; URO TOUCH
K130368 · FFK Lithotriptor,... · Gastroenterology & Urology
Nov 2013 274d
NEBULAE I
K120151 · HIF Insufflator, Laparoscopic · Obstetrics & Gynecology
Aug 2012 212d
FLO-ASSISTANT
K041560 · HIF Insufflator, Laparoscopic · Obstetrics & Gynecology
Sep 2004 110d
MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
K033614 · HIF Insufflator, Laparoscopic · Obstetrics & Gynecology
Jul 2004 255d
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
K022052 · HIF Insufflator, Laparoscopic · Obstetrics & Gynecology
Jan 2003 214d
HUMI-FLOW, MODEL 6-850-00/ 01/02
K010053 · HIF Insufflator, Laparoscopic · Obstetrics & Gynecology
Oct 2001 288d
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
K011928 · FPA Set, Administration,... · General Hospital
Aug 2001 51d
FLO ASSISTANT, MODEL 4-250-00
K001325 · LJH System, Irrigation,... · Gastroenterology & Urology
Aug 2000 114d
HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
K993778 · OCX Endoscopic... · Gastroenterology & Urology
Jan 2000 59d
CO2 GAS WARMER II, MODEL 6-800-00
K992381 · HIF Insufflator, Laparoscopic · Obstetrics & Gynecology
Sep 1999 63d
ELECTRO MECHANICAL LITHOTRIPTOR
K990341 · FFK Lithotriptor,... · Gastroenterology & Urology
Jul 1999 161d
OMNIFLATOR 7640 MODEL 7-640-00
K983326 · HIF Insufflator, Laparoscopic · Obstetrics & Gynecology
Feb 1999 136d
CO2 GAS WARMING UNIT (6-800-00)
K972675 · HIF Insufflator, Laparoscopic · Obstetrics & Gynecology
Sep 1998 441d
OMNIFLATOR 6630(6-630-00)
K973447 · HIF Insufflator, Laparoscopic · Obstetrics & Gynecology
Sep 1998 384d
FLUID CENTURION (4-100-00)
K973025 · FLN Monitor, Electric For... · General Hospital
Nov 1997 98d
ELECTROSURGICAL ELECRTRODES
K962271 · HIH Hysteroscope (and... · Obstetrics & Gynecology
Aug 1997 421d
VAPOR-TECH SLED ELECTRODE
K970717 · FAS Electrode,... · Gastroenterology & Urology
May 1997 70d
CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)
K964196 · OCX Endoscopic... · Gastroenterology & Urology
Dec 1996 63d
VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.
K954710 · FAS Electrode,... · Gastroenterology & Urology
Apr 1996 195d
HYDROLOGY 5000
K955339 · GBX Catheter, Irrigation · General & Plastic Surgery
Mar 1996 114d
NORTHGATE FLOW ASSIST TUBING FOR UROLOGY
K943361 · LJH System, Irrigation,... · Gastroenterology & Urology
Sep 1995 443d
PULSE GUARD 3FR ELECTRODE
K944571 · FFK Lithotriptor,... · Gastroenterology & Urology
Mar 1995 179d
LAPAROVIEW
K931065 · HET Laparoscope, Gynecologic... · Obstetrics & Gynecology
Nov 1994 639d
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