510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931876Substantially Equivalent

Fisk Arm Support

Vvortex International Corp., Rancho Cordova CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931876 is the FDA 510(k) clearance record for FISK ARM SUPPORT, a class I device, cleared for Vvortex International Corp. on under FDA product code FWW (Table, Operating-Room, Pneumatic). FDA records list one 510(k) clearance for Vvortex International Corp. As of , FDA records show no recalls naming K931876.

Clearance record

Decision date
Received
(148 days to decision)
Product code
FWW Table, Operating-Room, Pneumatic
Regulation
21 CFR 878.4960
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Vvortex International Corp. 11321 Trade Center Dr.,, Rancho Cordova CA
510(k) summary
Statement
Third party review
No

Clearances, product code FWW

Trailing 12 months

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

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