ANDREWS INTRODUCER, MODEL ASI01— 510(k) K023173

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..

Clearance details

Applicant: Andrews Surgical Innovations, Ltd.
Product code: Code MDM
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 ↗

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.