ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)— 510(k) K993190

Name: FDA 510(k) clearance K993190
Creator: U.S. Food and Drug Administration
Published: 2000-02-10

Substantially Equivalent

Surgical Instrument Systems (Sis), Ltd.

FDA 510(k) clearance K993190 for ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS), Substantially Equivalent on 2000-02-10. Applicant: Surgical Instrument Systems (Sis), Ltd.. Device class: 1.

Clearance details

Applicant: Surgical Instrument Systems (Sis), Ltd.
Product code: Code HNO
Device class: Class 1
Regulation: 21 CFR 886.4370
Advisory panel: Ophthalmic
Date received: 1999-09-23
Decision date: 2000-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HNO

product code HNO

Injury: 390
Total: 390

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.