SOFTRANS INJECTOR— 510(k) K913626

Name: FDA 510(k) clearance K913626
Creator: U.S. Food and Drug Administration
Published: 1991-12-18

Substantially Equivalent

Staar Surgical Co.

FDA 510(k) clearance K913626 for SOFTRANS INJECTOR, Substantially Equivalent on 1991-12-18. Applicant: Staar Surgical Co.. Device class: 3.

Clearance details

Applicant: Staar Surgical Co.
Product code: Code HQL
Device class: Class 3
Regulation: 21 CFR 886.3600
Advisory panel: Ophthalmic
Date received: 1991-08-15
Decision date: 1991-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, US

Download summary PDF View on FDA.gov ↗

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K771933 — CILCO ANTERIOR CHAMBER LENS1978-01-26

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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 HQL

product code HQL

Injury: 7,145
Malfunction: 15,684
Other: 5
Total: 22,834

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.