InnoSEAL Hemostatic Pad— 510(k) K161013

Substantially Equivalent

Innotherapy, Inc.

FDA 510(k) clearance K161013 for InnoSEAL Hemostatic Pad, Substantially Equivalent on 2016-11-29. Applicant: Innotherapy, Inc..

Clearance details

Applicant: Innotherapy, Inc.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2016-04-11
Decision date: 2016-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.