Northgate Technologies, Inc.
Northgate Technologies, Inc. holds FDA 510(k) medical device clearances, first cleared 1991, most recent 2021, with 9 FDA device recalls on record.
Top product codes for Northgate Technologies, Inc.
FDA recalls by Northgate Technologies, Inc.
- Z-1235-2022 — AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
- Z-0333-2022 — 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 fragmentation of calculi.
- Z-1147-2021 — 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 instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery).
- Z-1148-2021 — 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 a gastrointestinal endoscope.
- Z-1883-2020 — Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
- Z-1884-2020 — 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.
- Z-1885-2020 — 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 calculi.
- Z-0073-2018 — 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 fragmented and removed percutaneously or endoscopically.
- Z-0866-2017 — 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 operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Northgate Technologies, Inc.
- K202813 — URO-TOUCH 9 French Probe
- K202944 — NEBULAE SRS Laparoscopic Surgical Smoke Removal System
- K130368 — AUTOLITH TOUCH; URO TOUCH
- K120151 — NEBULAE I
- K041560 — FLO-ASSISTANT
- K033614 — MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
- K022052 — 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
- K010053 — HUMI-FLOW, MODEL 6-850-00/ 01/02
- K011928 — HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
- K001325 — FLO ASSISTANT, MODEL 4-250-00
- K993778 — HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
- K992381 — CO2 GAS WARMER II, MODEL 6-800-00
- K990341 — ELECTRO MECHANICAL LITHOTRIPTOR
- K983326 — OMNIFLATOR 7640 MODEL 7-640-00
- K972675 — CO2 GAS WARMING UNIT (6-800-00)
- K973447 — OMNIFLATOR 6630(6-630-00)
- K973025 — FLUID CENTURION (4-100-00)
- K962271 — ELECTROSURGICAL ELECRTRODES
- K970717 — VAPOR-TECH SLED ELECTRODE
- K964196 — CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)
- K954710 — VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.
- K955339 — HYDROLOGY 5000
- K943361 — NORTHGATE FLOW ASSIST TUBING FOR UROLOGY
- K944571 — PULSE GUARD 3FR ELECTRODE
- K931065 — LAPAROVIEW
- K930912 — HYSTEROMED 100
- K935862 — NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600
- K925396 — PULSE GUARD ELECTRODE
- K923822 — AUTOLITH-IEHL
- K921088 — EVACUATOR, GASTRO-UROLOGY
- K921451 — EVACUATOR, GASTRO-UROLOGY
- K914517 — SD-200IEHL(TM)
- K915051 — MODIFICATION MODEL 7201 INSUFFLATOR
- K914861 — EVACUATION KIT #7-510-14
- K914515 — 3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
- K914516 — 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
- K914514 — 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
- K913955 — 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
- K914401 — UNIVERSAL GENERAL USE KIT #7-510-16
- K914402 — RECIRCULATION KIT #7-510-18
- K914403 — GENERAL USE KIT #7-510-20
- K911179 — VERRES NEEDLES 5 & 6 INCHES
- K913992 — ASPIRATION/INJECTION NEEDLE
- K911364 — SPOON FORCEPS, 11MM
- K913991 — GRASPER, RATCHETED (5MM X 30CM)
- K911312 — SUCTION/IRRIGATION TUBE & TUBE WITH CHANNEL
- K911243 — CHOLANGIOCATH AND ATRAUMATIC BOWEL CLAMP
- K911365 — ELECTROCAUTERY CABLE, BOVIE(TM)/BANANA PLUGS
- K911316 — INSULATED HOOK SCISSORS/J & L HOOK KNIVES/SPATULA
- K905117 — ENDOSCOPE AND ACCESSORIES
- K911157 — APPLICATOR LOOP SUTURES
- K905481 — NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR
- K911158 — MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM
- K911159 — PALPATION PROBE
- K911180 — CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS
Data sourced from openFDA. This site is unofficial and independent of the FDA.