Northgate Technologies, Inc.: FDA clearances and approvals
Northgate Technologies, Inc. has 55 FDA 510(k) clearances (first 1991, latest 2021), across 21 product codes in 4 review panels. Median 510(k) review time: 136 days. openFDA lists 10 product recalls by a recalling firm named Northgate Technologies, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 212 |
| 2013 | 1 | 274 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 220 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Northgate Technologies, Inc.'s cleared 510(k)s took a median 220 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | 16 | 16 |
| FFK | Lithotriptor, Electro-Hydraulic | 11 | 11 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| FAS | Electrode, Electrosurgical, Active, Urological | 2 | 2 |
| KQT | Evacuator, Gastro-Urology | 2 | 2 |
| LJH | System, Irrigation, Urological | 2 | 2 |
| OCX | Endoscopic Irrigation/Suction System | 2 | 2 |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Plus 11 more product codes.
Review panels
- Gastroenterology and Urology (20)
- Obstetrics and Gynecology (19)
- General and Plastic Surgery (13)
- General Hospital (3)
Most recent Northgate Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202813 | URO-TOUCH 9 French Probe | FFK | 2021-06-14 | 263 |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | FYD | 2021-03-25 | 176 |
| K130368 | AUTOLITH TOUCH; URO TOUCH | FFK | 2013-11-15 | 274 |
| K120151 | NEBULAE I | HIF | 2012-08-17 | 212 |
| K041560 | FLO-ASSISTANT | HIF | 2004-09-28 | 110 |
| K033614 | MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 | HIF | 2004-07-29 | 255 |
| K022052 | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 | HIF | 2003-01-24 | 214 |
| K010053 | HUMI-FLOW, MODEL 6-850-00/ 01/02 | HIF | 2001-10-23 | 288 |
| K011928 | HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 | FPA | 2001-08-10 | 51 |
| K001325 | FLO ASSISTANT, MODEL 4-250-00 | LJH | 2000-08-18 | 114 |
45 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 7 recall events; 2 initiated in the last five years. Most recent: 2022-04-13.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Northgate Technologies, Inc. have?
Northgate Technologies, Inc. has 55 FDA 510(k) clearances (first 1991, latest 2021), across 21 product codes in 4 review panels.
How long does FDA take to clear Northgate Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Northgate Technologies, Inc.'s cleared 510(k)s is 136 days.
What devices does Northgate Technologies, Inc. make?
Its most frequent FDA product codes are HIF (Insufflator, Laparoscopic, 16); FFK (Lithotriptor, Electro-Hydraulic, 11); GCJ (Laparoscope, General & Plastic Surgery, 4).
Has Northgate Technologies, Inc. had device recalls?
openFDA lists 10 product recalls in 7 recall events by a recalling firm whose name matches Northgate Technologies, Inc; the most recent began 2022-04-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 55 Northgate Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIF, Northgate Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.