Northgate Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 55
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1235-2022 | Class II | AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe | April 13, 2022 |
| Z-0333-2022 | Class II | Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device | October 25, 2021 |
| Z-1147-2021 | Class II | ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device wil | January 15, 2021 |
| Z-1148-2021 | Class II | Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: d | January 15, 2021 |
| Z-1884-2020 | Class II | AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for | March 10, 2020 |
| Z-1885-2020 | Class II | ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog N | March 10, 2020 |
| Z-1883-2020 | Class II | Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmenta | March 10, 2020 |
| Z-0073-2018 | Class II | Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Aut | May 24, 2017 |
| Z-0866-2017 | Class II | Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insuff | November 21, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K202813 | URO-TOUCH 9 French Probe | June 14, 2021 |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | March 25, 2021 |
| K130368 | AUTOLITH TOUCH; URO TOUCH | November 15, 2013 |
| K120151 | NEBULAE I | August 17, 2012 |
| K041560 | FLO-ASSISTANT | September 28, 2004 |
| K033614 | MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 | July 29, 2004 |
| K022052 | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 | January 24, 2003 |
| K010053 | HUMI-FLOW, MODEL 6-850-00/ 01/02 | October 23, 2001 |
| K011928 | HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 | August 10, 2001 |
| K001325 | FLO ASSISTANT, MODEL 4-250-00 | August 18, 2000 |
| K993778 | HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 | January 6, 2000 |
| K992381 | CO2 GAS WARMER II, MODEL 6-800-00 | September 17, 1999 |
| K990341 | ELECTRO MECHANICAL LITHOTRIPTOR | July 14, 1999 |
| K983326 | OMNIFLATOR 7640 MODEL 7-640-00 | February 5, 1999 |
| K972675 | CO2 GAS WARMING UNIT (6-800-00) | September 30, 1998 |
| K973447 | OMNIFLATOR 6630(6-630-00) | September 30, 1998 |
| K973025 | FLUID CENTURION (4-100-00) | November 20, 1997 |
| K962271 | ELECTROSURGICAL ELECRTRODES | August 8, 1997 |
| K970717 | VAPOR-TECH SLED ELECTRODE | May 8, 1997 |
| K964196 | CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00) | December 23, 1996 |