510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K860173Substantially Equivalent

Vis-2000 Video System

Vistek Corp., Santa Barbara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860173 is the FDA 510(k) clearance record for VIS-2000 VIDEO SYSTEM, a class I device, cleared for Vistek Corp. on under FDA product code FWG (Camera, Television, Endoscopic, With Audio). FDA records list 5 510(k) clearances for Vistek Corp., from to . As of , FDA records show no recalls naming K860173.

Clearance record

Decision date
Received
(21 days to decision)
Product code
FWG Camera, Television, Endoscopic, With Audio
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Vistek Corp. 4 E. Yanonali St., Santa Barbara CA
Third party review
No

Clearances, product code FWG

Trailing 12 months

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

FDA records show no clearances under product code FWG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FWG, 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