510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925108Substantially Equivalent

Integrated Visualization System

Neuro Navigational Corp., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925108 is the FDA 510(k) clearance record for INTEGRATED VISUALIZATION SYSTEM, a class I device, cleared for Neuro Navigational Corp. on under FDA product code FWF (Camera, Television, Endoscopic, Without Audio). FDA records list 23 510(k) clearances for Neuro Navigational Corp., from to . As of , FDA records show no recalls naming K925108.

Clearance record

Decision date
Received
(112 days to decision)
Product code
FWF Camera, Television, Endoscopic, Without Audio
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Neuro Navigational Corp. 3180 Pullman St., Costa Mesa CA
510(k) summary
Statement
Third party review
No

Clearances, product code FWF

Trailing 12 months

FDA records hold no clearances under product code FWF in the trailing twelve months.

FDA records show no clearances under product code FWF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FWF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260