Neuro Navigational Corp.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Neuro Navigational Corp.” (first 1993, latest 1997), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 83 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWG | Endoscope, Neurological | 15 | 15 |
| HRX | Arthroscope | 5 | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| FWF | Camera, Television, Endoscopic, Without Audio | 1 | 1 |
Review panels
- Neurology (15)
- Orthopedic (5)
- General and Plastic Surgery (3)
Most recent Neuro Navigational Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K965078 | 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS | GWG | 1997-03-06 | 77 |
| K961406 | NEUROVIEW SCISSORS | GWG | 1996-06-13 | 63 |
| K961300 | ASPIRATION/IRRIGATION CATHETER | GWG | 1996-06-07 | 64 |
| K961173 | 1.2MM REUSABLE NEUROVIEW ENDOSCOPE | GWG | 1996-06-07 | 74 |
| K960792 | DISPOSABLE NEUROVIEW INTRODUCER SHEATH | GWG | 1996-04-11 | 44 |
| K954938 | DISPOSABLE NEUROVIEW OPERATING SHEATH | GWG | 1996-03-07 | 129 |
| K955351 | NEUROVIEW COAXIAL BIPOLAR ELECTRODE | GWG | 1996-02-29 | 100 |
| K954899 | RIGID NEUROVIEW ENDOSCOPE | GWG | 1995-12-19 | 55 |
| K955467 | NEUROVIEW COAXIAL BIPOLAR ELECTRODE | GEI | 1995-12-18 | 18 |
| K955037 | RIGID NEUROVIEW ENDOSCOPE | HRX | 1995-12-04 | 31 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Neuro Navigational Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Neuro Supplies, Inc. (5 510(k)s)
- Neuro Technology (5 510(k)s)
- Neuro Kinetics, Inc. (4 510(k)s)
- Neuro Resource Group, Inc. (4 510(k)s)
- Neuro Scan Labs (3 510(k)s)
- Neuro Therm, Inc. (3 510(k)s)
- Neuro Vasx, Inc. (2 510(k)s)
- Neuro Diagnostic Devices (1 510(k)s)
- Neuro Event Labs OY (1 510(k)s)
- Neuro Spinal Innovation, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Neuro Navigational Corp.?
FDA lists 23 510(k) clearances under the applicant name “Neuro Navigational Corp.” (first 1993, latest 1997), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neuro Navigational Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neuro Navigational Corp. is 83 days.
Which FDA product codes appear under Neuro Navigational Corp.?
The most frequent FDA product codes under this applicant name are GWG (Endoscope, Neurological, 15); HRX (Arthroscope, 5); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2).
Next steps
- See all 23 Neuro Navigational Corp. clearances with predicates and recalls
- Run predicate analysis for product code GWG, Neuro Navigational Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.