510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874276Substantially Equivalent

Cui, Versafil(tm), Ste(tm) Tissue Expander

Cox-Uphuff Intl., Santa Barbara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874276 is the FDA 510(k) clearance record for CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER, a class I device, cleared for Cox-Uphuff Intl. on under FDA product code FZW (Expander, Surgical, Skin Graft). FDA records list 11 510(k) clearances for Cox-Uphuff Intl., from to . As of , FDA records show no recalls naming K874276.

Clearance record

Decision date
Received
(43 days to decision)
Product code
FZW Expander, Surgical, Skin Graft
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Cox-Uphuff Intl. P.O. Box 40288, Santa Barbara CA
Third party review
No

Clearances, product code FZW

Trailing 12 months

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

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