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

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..

Clearance details

Applicant: Surgin Surgical Instrumentation, Inc.
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 1999-11-26
Decision date: 2000-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

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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.