K994015

Substantially Equivalent

ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508

Applicant: Surgin Surgical Instrumentation, Inc.
Product 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

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.