Chrysalis Intelligence · Sponsors · Northgate Technologies, Inc.

Northgate Technologies, Inc.

Elgin, IL, US · 2 510(k) clearances · 7 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals

Total clearances

2

2021-03-25 → 2021-06-14

Last 12 months

0

Product codes

2

Most recent

2021-06-14

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
FFK	Lithotriptor, Electro-Hydraulic	Class II	Gastroenterology, Urology	1	2021-06-14
FYD	Apparatus, Exhaust, Surgical	Class II	General, Plastic Surgery	1	2021-03-25

Safety

Recalls (7)

Class I (serious)

0

Risk of injury / death

Total recalls

7

Currently ongoing

1

Most recent

2022-04-13

Date	Severity	Status	Recall #	Product	Code	Reason
2022-04-13	Class II	Terminated	Z-1235-2022	AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe	—	Product labeled incorrectly.
2021-10-25	Class II	Ongoing	Z-0333-2022	Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be us…	—	The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
2021-01-15	Class II	Terminated	Z-1148-2021	Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 a…	—	An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
2021-01-15	Class II	Terminated	Z-1147-2021	ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expand…	—	An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
2020-03-10	Class II	Terminated	Z-1885-2020	ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - P…	—	Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2020-03-10	Class II	Terminated	Z-1884-2020	AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of…	—	Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2020-03-10	Class II	Terminated	Z-1883-2020	Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/rena…	—	As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

Filings

All 510(k) clearances (2)

Date	K-number	Device	Code	Class	Specialty
2021-06-14	K202813	URO-TOUCH 9 French Probe	FFK	Class II	Gastroenterology, Urology
2021-03-25	K202944	NEBULAE SRS Laparoscopic Surgical Smoke Removal System	FYD	Class II	General, Plastic Surgery