DeviceClearance

K011195

Substantially Equivalent

PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB

Applicant
Surgin Surgical Instrumentation, Inc.
Product code
HNO
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tustin, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HNO

product code HNO
Injury
390
Total
390

Source: openFDA MAUDE database, through . 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.