AMT Enteral Transition Adapters— 510(k) K150034

Name: FDA 510(k) clearance K150034
Creator: U.S. Food and Drug Administration
Published: 2015-06-09

Substantially Equivalent

Applied Medical Technology, Inc.

FDA 510(k) clearance K150034 for AMT Enteral Transition Adapters, Substantially Equivalent on 2015-06-09. Applicant: Applied Medical Technology, Inc.. Device class: 2.

Clearance details

Applicant: Applied Medical Technology, Inc.
Product code: Code PIO
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2015-01-09
Decision date: 2015-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brecksville, OH, US

Download summary PDF View on FDA.gov ↗

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K162254 — Cedic Enteral ENFit Transition Connectors2017-05-04
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Recalls naming K150034

K-number listed on FDA's recall record

Z-0698-2021 — AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075Class III·Terminated·Applied Medical Technology Inc·20201110

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150034.

Data sourced from openFDA. This site is unofficial and independent of the FDA.