ABCcolla Collagen Matrix— 510(k) K162348

Substantially Equivalent

Acro Biomedical Co., Ltd.

FDA 510(k) clearance K162348 for ABCcolla Collagen Matrix, Substantially Equivalent on 2017-05-10. Applicant: Acro Biomedical Co., Ltd..

Clearance details

Applicant: Acro Biomedical Co., Ltd.
Product code: Code KGN
Advisory panel: Unknown
Date received: 2016-08-22
Decision date: 2017-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaohsiung City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

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.