Neuro Navigational Corp.
Costa Mesa, CA, US
Neuro Navigational Corp. appears in FDA device records in Costa Mesa, CA. FDA records list 23 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Neuro Navigational Corp. between 1993 and 1997. The busiest year on record is 1995, with 10. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 5 |
| 1994 | 1 |
| 1995 | 10 |
| 1996 | 6 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K965078 | 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS | GWG | Substantially Equivalent | |
| K961406 | NEUROVIEW SCISSORS | GWG | Substantially Equivalent | |
| K961300 | ASPIRATION/IRRIGATION CATHETER | GWG | Substantially Equivalent | |
| K961173 | 1.2MM REUSABLE NEUROVIEW ENDOSCOPE | GWG | Substantially Equivalent | |
| K960792 | DISPOSABLE NEUROVIEW INTRODUCER SHEATH | GWG | Substantially Equivalent | |
| K954938 | DISPOSABLE NEUROVIEW OPERATING SHEATH | GWG | Substantially Equivalent | |
| K955351 | NEUROVIEW COAXIAL BIPOLAR ELECTRODE | GWG | Substantially Equivalent | |
| K954899 | RIGID NEUROVIEW ENDOSCOPE | GWG | Substantially Equivalent | |
| K955467 | NEUROVIEW COAXIAL BIPOLAR ELECTRODE | GEI | Substantially Equivalent | |
| K955037 | RIGID NEUROVIEW ENDOSCOPE | HRX | Substantially Equivalent for Some Indications | |
| K952639 | DISPOSABLE TOOTHED GRASPING FORCEP | HRX | Substantially Equivalent | |
| K952630 | DISPOSABLE BIOPSY FORCEP | HRX | Substantially Equivalent | |
| K952832 | DISPOSABLE BIPOLAR ELECTRODE | GEI | Substantially Equivalent | |
| K950154 | 1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES | GWG | Substantially Equivalent | |
| K950705 | 1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE | HRX | Substantially Equivalent | |
| K940483 | 2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE | HRX | Substantially Equivalent for Some Indications | |
| K934154 | DISPOSABLE ASPIRATION/IRRIGATION CATHETER | GWG | Substantially Equivalent | |
| K942955 | DISPOSABLE BIPOLAR ELECTRODE | GWG | Substantially Equivalent | |
| K931973 | DISPOSABLE PEEL-AWAY INTRODUCER SHEATH | GWG | Substantially Equivalent | |
| K933244 | DISPOSABLE GRASPING FORCEP | GWG | Substantially Equivalent | |
| K925881 | DISPOSABLE BIOPSY FORCEP | GWG | Substantially Equivalent | |
| K923479 | DISPOSABLE NEUROVIEW ENDOSCOPE | GWG | Substantially Equivalent | |
| K925108 | INTEGRATED VISUALIZATION SYSTEM | FWF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain