510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013162Substantially Equivalent

14F X 24Cm Ash Split-Cath,14f X 28Cm Ash Split-Cath, 14F X 32Cm Ash Split-Cath, 14Fx36cm Ash Split-Cath, 14F X 40Cm Ash

Medcomp, Harleysville PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K013162 is the FDA 510(k) clearance record for 14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH, a class II device, cleared for Medcomp on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 40 510(k) clearances for Medcomp, from to . As of , FDA records show no recalls naming K013162.

Clearance record

Decision date
Received
(28 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medcomp 1499 Delp Dr., Harleysville PA
510(k) summary
Summary
Third party review
No

Clearances, product code KNT

Trailing 12 months
2 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 20260
October 20260