AFX INTRODUCER SYSTEM— 510(k) K120212

Name: FDA 510(k) clearance K120212
Creator: U.S. Food and Drug Administration
Published: 2012-02-09

Substantially Equivalent

Endologix, Inc.

FDA 510(k) clearance K120212 for AFX INTRODUCER SYSTEM, Substantially Equivalent on 2012-02-09. Applicant: Endologix, Inc.. Device class: 2.

Clearance details

Applicant: Endologix, Inc.
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2012-01-24
Decision date: 2012-02-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Endologix, Inc.

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K111747 — ENDOLOGIX AFX INTRODUCER SYSTEM2011-07-12
K110090 — AFX INTRODUCER SYSTEM2011-05-26
K080360 — ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER2008-04-08
K991601 — DUAL LUMEN CATHETER, MODEL DL-35-901999-10-28

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K120212

K-number listed on FDA's recall record

Z-1436-2013 — Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.Class I·Terminated·Endologix Inc·20130513

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120212.

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