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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Neuro Navigational Corp. — Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

83 daysmedian FDA review time
219 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K9650782.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVNeuro Navigational Corp.1997-03-06770
K961406NEUROVIEW SCISSORSNeuro Navigational Corp.1996-06-13630
K961300ASPIRATION/IRRIGATION CATHETERNeuro Navigational Corp.1996-06-07640
K9611731.2MM REUSABLE NEUROVIEW ENDOSCOPENeuro Navigational Corp.1996-06-07740
K960792DISPOSABLE NEUROVIEW INTRODUCER SHEATHNeuro Navigational Corp.1996-04-11440
K954938DISPOSABLE NEUROVIEW OPERATING SHEATHNeuro Navigational Corp.1996-03-071290
K955351NEUROVIEW COAXIAL BIPOLAR ELECTRODENeuro Navigational Corp.1996-02-291000
K954899RIGID NEUROVIEW ENDOSCOPENeuro Navigational Corp.1995-12-19550
K955467NEUROVIEW COAXIAL BIPOLAR ELECTRODENeuro Navigational Corp.1995-12-18180
K955037RIGID NEUROVIEW ENDOSCOPENeuro Navigational Corp.1995-12-04310
K952630DISPOSABLE BIOPSY FORCEPNeuro Navigational Corp.1995-09-08920
K952639DISPOSABLE TOOTHED GRASPING FORCEPNeuro Navigational Corp.1995-09-08910
K952832DISPOSABLE BIPOLAR ELECTRODENeuro Navigational Corp.1995-07-26360
K9501541.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESNeuro Navigational Corp.1995-07-141780
K9507051.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPENeuro Navigational Corp.1995-05-09830
K9404832.3 MM DISPOSABLE NEUROVIEW ENDOSCOPENeuro Navigational Corp.1995-05-024540
K934154DISPOSABLE ASPIRATION/IRRIGATION CATHETERNeuro Navigational Corp.1995-02-215430
K942955DISPOSABLE BIPOLAR ELECTRODENeuro Navigational Corp.1994-08-03410
K931973DISPOSABLE PEEL-AWAY INTRODUCER SHEATHNeuro Navigational Corp.1993-09-141450
K933244DISPOSABLE GRASPING FORCEPNeuro Navigational Corp.1993-09-10700
K923479DISPOSABLE NEUROVIEW ENDOSCOPENeuro Navigational Corp.1993-02-192190
K925881DISPOSABLE BIOPSY FORCEPNeuro Navigational Corp.1993-02-19920
K925108INTEGRATED VISUALIZATION SYSTEMNeuro Navigational Corp.1993-01-291120

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda