ANDREWS INTRODUCER, MODEL ASI01— 510(k) K023173

Name: FDA 510(k) clearance K023173
Creator: U.S. Food and Drug Administration
Published: 2002-12-18

Substantially Equivalent

Andrews Surgical Innovations, Ltd.

FDA 510(k) clearance K023173 for ANDREWS INTRODUCER, MODEL ASI01, Substantially Equivalent on 2002-12-18. Applicant: Andrews Surgical Innovations, Ltd.. Device class: 1.

Clearance details

Applicant: Andrews Surgical Innovations, Ltd.
Product code: Code MDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 2002-09-23
Decision date: 2002-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Co. Dublin, IE

Download summary PDF View on FDA.gov ↗

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K022059 — MICROVASIVE PULMONARY GUIDEWIRE2002-11-13
K013040 — LIGHT SABER INTRODUCER NEEDLE2001-12-07

Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.