510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862564Substantially Equivalent

A.c.l. Guide Kit

Aspen Laboratories, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862564 is the FDA 510(k) clearance record for A.C.L. GUIDE KIT, a class I device, cleared for Aspen Laboratories, Inc. on under FDA product code FZX (Guide, Surgical, Instrument). FDA records list 55 510(k) clearances for Aspen Laboratories, Inc., from to . As of , FDA records show no recalls naming K862564.

Clearance record

Decision date
Received
(46 days to decision)
Product code
FZX Guide, Surgical, Instrument
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Aspen Laboratories, Inc. P.O. Box 3936, Englewood CO
Third party review
No

Clearances, product code FZX

Trailing 12 months

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

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