INSUFLOW SYNERGY XL PORT— 510(k) K132204

Name: FDA 510(k) clearance K132204
Creator: U.S. Food and Drug Administration
Published: 2013-08-22

Substantially Equivalent

Lexion Medical, LLC

FDA 510(k) clearance K132204 for INSUFLOW SYNERGY XL PORT, Substantially Equivalent on 2013-08-22. Applicant: Lexion Medical, LLC. Device class: 2.

Clearance details

Applicant: Lexion Medical, LLC
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 2013-07-16
Decision date: 2013-08-22
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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K250388 — ENDOFLATOR +2025-09-22
K242772 — AirSurgN Insufflator (10030/AirSurgN)2025-04-11

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K191780 — AP50/30 Insufflator with Insuflow Port2019-08-28
K170799 — AP 50/30 Insufflator with Insuflow Port2017-11-14
K140263 — INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT2014-03-05
K132203 — PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA2013-09-20
K120640 — INSUFLOW SYNERGY PORT2012-07-18

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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 →

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