510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854988Substantially Equivalent

Ky-M280u Surgical Camera

Us Jvc Corp., Elmwood Park NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854988 is the FDA 510(k) clearance record for KY-M280U SURGICAL CAMERA, a class I device, cleared for Us Jvc Corp. on under FDA product code FWC (Camera, Television, Surgical, With Audio). FDA records list one 510(k) clearance for Us Jvc Corp. As of , FDA records show no recalls naming K854988.

Clearance record

Decision date
Received
(43 days to decision)
Product code
FWC Camera, Television, Surgical, With Audio
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Us Jvc Corp. 41 Slater Dr., Elmwood Park NJ
Third party review
No

Clearances, product code FWC

Trailing 12 months

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

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