510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854888Substantially Equivalent

Randall Curette

Euro-Med Intl., Danville CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854888 is the FDA 510(k) clearance record for RANDALL CURETTE, a class I device, cleared for Euro-Med Intl. on under FDA product code FZS (Curette, Surgical, General Use). FDA records list 16 510(k) clearances for Euro-Med Intl., from to . As of , FDA records show no recalls naming K854888.

Clearance record

Decision date
Received
(18 days to decision)
Product code
FZS Curette, Surgical, General Use
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Euro-Med Intl. Advanced Biosearch Associates, Danville CA
Third party review
No

Clearances, product code FZS

Trailing 12 months

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

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