ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508— 510(k) K994015

Name: FDA 510(k) clearance K994015
Creator: U.S. Food and Drug Administration
Published: 2000-03-15

Substantially Equivalent

Surgin Surgical Instrumentation, Inc.

FDA 510(k) clearance K994015 for ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508, Substantially Equivalent on 2000-03-15. Applicant: Surgin Surgical Instrumentation, Inc.. Device class: 1.

Clearance details

Applicant: Surgin Surgical Instrumentation, Inc.
Product code: Code HNO
Device class: Class 1
Regulation: 21 CFR 886.4370
Advisory panel: Ophthalmic
Date received: 1999-11-26
Decision date: 2000-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, 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.