510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861592Substantially Equivalent

Wec-Wash, Catalog No. 850-115

Palmetto Chemical & Supply Co., Inc., Monroe NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861592 is the FDA 510(k) clearance record for WEC-WASH, CATALOG NO. 850-115, a class I device, cleared for Palmetto Chemical & Supply Co., Inc. on under FDA product code FLG (Cleaner, Ultrasonic, Medical Instrument). FDA records list 6 510(k) clearances for Palmetto Chemical & Supply Co., Inc., from to . As of , FDA records show no recalls naming K861592.

Clearance record

Decision date
Received
(49 days to decision)
Product code
FLG Cleaner, Ultrasonic, Medical Instrument
Regulation
21 CFR 880.6150
Device class
Class I
Review panel
General Hospital
Applicant
Palmetto Chemical & Supply Co., Inc. 600 Stitt St., Monroe NC
Third party review
No

Clearances, product code FLG

Trailing 12 months

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

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