OPHTHALMIC KNIFE & FORCEPS— 510(k) K864266

Name: FDA 510(k) clearance K864266
Creator: U.S. Food and Drug Administration
Published: 1986-11-28

Substantially Equivalent

Western Medical Products, Inc.

FDA 510(k) clearance K864266 for OPHTHALMIC KNIFE & FORCEPS, Substantially Equivalent on 1986-11-28. Applicant: Western Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Western Medical Products, Inc.
Product code: Code HNR
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1986-10-29
Decision date: 1986-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sherman Oaks, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HNR

product code HNR

Malfunction: 497
Other: 1
Total: 498

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.