MASTEL 1 FOLDER IMPLANTATION SYSTEM— 510(k) K022723

Substantially Equivalent

Mastel Precision, Inc.

FDA 510(k) clearance K022723 for MASTEL 1 FOLDER IMPLANTATION SYSTEM, Substantially Equivalent on 2002-12-26. Applicant: Mastel Precision, Inc..

Clearance details

Applicant: Mastel Precision, Inc.
Product code: Code KYB
Advisory panel: Ophthalmic
Date received: 2002-08-16
Decision date: 2002-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KYB

product code KYB

Injury: 218
Malfunction: 1,989
Other: 1
Total: 2,208

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.