510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K043258Substantially Equivalent

Modified Tfx Medical Safety Needle with Introducer, Part No. T4634-02

Teleflex Medical, Jaffery NH / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043258 is the FDA 510(k) clearance record for MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02, a class II device, cleared for Teleflex Medical on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 80 510(k) clearances for Teleflex Medical, from to . As of , FDA records show no recalls naming K043258.

Clearance record

Decision date
Received
(22 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Teleflex Medical 50 Plantation Dr., Jaffery NH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNT

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