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
K880481Substantially Equivalent

Caretex Surgeon's Caps

James River Corp., Neenah WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880481 is the FDA 510(k) clearance record for CARETEX SURGEON'S CAPS, a class I device, cleared for James River Corp. on under FDA product code FYF (Cap, Surgical). FDA records list 15 510(k) clearances for James River Corp., from to . As of , FDA records show no recalls naming K880481.

Clearance record

Decision date
Received
(19 days to decision)
Product code
FYF Cap, Surgical
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
James River Corp. 1915 Marathon Ave., Neenah WI
Third party review
No

Clearances, product code FYF

Trailing 12 months

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

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