pioli IOL Delivery System— 510(k) K172228

Name: FDA 510(k) clearance K172228
Creator: U.S. Food and Drug Administration
Published: 2017-12-15

Substantially Equivalent

Ast Products, Inc.

FDA 510(k) clearance K172228 for pioli IOL Delivery System, Substantially Equivalent on 2017-12-15. Applicant: Ast Products, Inc.. Device class: 1.

Clearance details

Applicant: Ast Products, Inc.
Product code: Code MSS
Device class: Class 1
Regulation: 21 CFR 886.4300
Advisory panel: Ophthalmic
Date received: 2017-07-25
Decision date: 2017-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MSS

product code MSS

Injury: 385
Malfunction: 2,033
Total: 2,418

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.