AbClose - Port Site Closure Device— 510(k) K160117

Substantially Equivalent

Medeon Biodesign, Inc.

FDA 510(k) clearance K160117 for AbClose - Port Site Closure Device, Substantially Equivalent on 2016-09-09. Applicant: Medeon Biodesign, Inc..

Clearance details

Applicant: Medeon Biodesign, Inc.
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 2016-01-19
Decision date: 2016-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCW

product code OCW

Death: 6
Injury: 443
Malfunction: 1,023
Other: 2
Total: 1,474

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.