510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K843081Substantially Equivalent

Tugs-Transportable Univ. Gradient Suct

Creative Medical Laboratories, Inc., US / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843081 is the FDA 510(k) clearance record for TUGS-TRANSPORTABLE UNIV. GRADIENT SUCT, a class II device, cleared for Creative Medical Laboratories, Inc. on under FDA product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered). FDA records list one 510(k) clearance for Creative Medical Laboratories, Inc. As of , FDA records show no recalls naming K843081.

Clearance record

Decision date
Received
(66 days to decision)
Product code
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Creative Medical Laboratories, Inc. P.O. Box 6347, US
Third party review
No

Clearances, product code JCX

Trailing 12 months
1 clearance under product code JCX in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JCX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260