POLLY'S CUTTER J-225— 510(k) K914038

Substantially Equivalent

O.R. Specialties, Inc.

FDA 510(k) clearance K914038 for POLLY'S CUTTER J-225, Substantially Equivalent on 1991-12-09. Applicant: O.R. Specialties, Inc..

Clearance details

Applicant: O.R. Specialties, Inc.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1991-09-10
Decision date: 1991-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuscaloosa, AL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

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.