510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883654Substantially Equivalent

Steri-Tag(tm) Sterile Label Sets

Acacia Laboratories, Inc., Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883654 is the FDA 510(k) clearance record for STERI-TAG(TM) STERILE LABEL SETS, a class I device, cleared for Acacia Laboratories, Inc. on under FDA product code LYV (Label Or Tag, Sterile). FDA records list 12 510(k) clearances for Acacia Laboratories, Inc., from to . As of , FDA records show no recalls naming K883654.

Clearance record

Decision date
Received
(48 days to decision)
Product code
LYV Label Or Tag, Sterile
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Acacia Laboratories, Inc. 1010 Hathaway Ave., Santa Ana CA
Third party review
No

Clearances, product code LYV

Trailing 12 months

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

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