510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K926166Substantially Equivalent

Coast Video Endoscopic Imaging System

Optik, Odenton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926166 is the FDA 510(k) clearance record for COAST VIDEO ENDOSCOPIC IMAGING SYSTEM, a class I device, cleared for Optik on under FDA product code FWF (Camera, Television, Endoscopic, Without Audio). FDA records list 2 510(k) clearances for Optik, from to . As of , FDA records show no recalls naming K926166.

Clearance record

Decision date
Received
(175 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
Optik 1370 Blair Dr., Odenton MD
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