510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861306Substantially Equivalent

Suction System

Axiom Medical, Inc., Paramount CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861306 is the FDA 510(k) clearance record for SUCTION SYSTEM, a class I device, cleared for Axiom Medical, Inc. on under FDA product code GEA (Cannula, Surgical, General & Plastic Surgery). FDA records list 28 510(k) clearances for Axiom Medical, Inc., from to . As of , FDA records show no recalls naming K861306.

Clearance record

Decision date
Received
(62 days to decision)
Product code
GEA Cannula, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Axiom Medical, Inc. 7625 Rosecrans Ave., Paramount CA
Third party review
No

Clearances, product code GEA

Trailing 12 months

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

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