510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K813526Substantially Equivalent

Fecal Sanitary Tube

Leon'S Fecal Sanitary Tub Mfg., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813526 is the FDA 510(k) clearance record for FECAL SANITARY TUBE, a class II device, cleared for Leon'S Fecal Sanitary Tub Mfg. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list one 510(k) clearance for Leon'S Fecal Sanitary Tub Mfg. As of , FDA records show no recalls naming K813526.

Clearance record

Decision date
Received
(27 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Leon'S Fecal Sanitary Tub Mfg. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KNT

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