FAULKNER FORCEPS— 510(k) K864071

Name: FDA 510(k) clearance K864071
Creator: U.S. Food and Drug Administration
Published: 1986-11-13

Substantially Equivalent

Staar Surgical Co.

FDA 510(k) clearance K864071 for FAULKNER FORCEPS, Substantially Equivalent on 1986-11-13. Applicant: Staar Surgical Co.. Device class: 1.

Clearance details

Applicant: Staar Surgical Co.
Product code: Code HNR
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1986-10-20
Decision date: 1986-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, US

Download summary PDF View on FDA.gov ↗

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K885230 — MCDONALD FOLDING FORCEPS1989-05-17

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K090161 — EPIPHANY INJECTION SYSTEM2009-06-09
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K073591 — MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM2008-03-13
K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S2004-06-10
K020734 — SURGE-FREE ASPIRATION ADAPTER2002-05-16

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.