K102686

Substantially Equivalent

MYOSURE ROD LENS SCOPE SEALS

Applicant: Interlace Medical, Inc.
Product code: HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2010-09-17
Decision date: 2010-10-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Framingham, MA, US

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.