PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB— 510(k) K011195

Substantially Equivalent

Surgin Surgical Instrumentation, Inc.

FDA 510(k) clearance K011195 for PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB, Substantially Equivalent on 2001-11-06. Applicant: Surgin Surgical Instrumentation, Inc..

Clearance details

Applicant: Surgin Surgical Instrumentation, Inc.
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 2001-04-19
Decision date: 2001-11-06
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.