510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934092Substantially Equivalent

Camera, Surgical and Accessories

Envision Medical Corp., Goleta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934092 is the FDA 510(k) clearance record for CAMERA, SURGICAL AND ACCESSORIES, a class I device, cleared for Envision Medical Corp. on under FDA product code FWB (Camera, Television, Surgical, Without Audio). FDA records list 5 510(k) clearances for Envision Medical Corp., from to . As of , FDA records show no recalls naming K934092.

Clearance record

Decision date
Received
(137 days to decision)
Product code
FWB Camera, Television, Surgical, Without Audio
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Envision Medical Corp. 7220 Hollister Ave., Goleta CA
510(k) summary
Statement
Third party review
No

Clearances, product code FWB

Trailing 12 months

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

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