ABCcolla® Collagen ADM Scaffold— 510(k) K233378

Substantially Equivalent

Acro Biomedical Co., Ltd.

FDA 510(k) clearance K233378 for ABCcolla® Collagen ADM Scaffold, Substantially Equivalent on 2024-10-18. Applicant: Acro Biomedical Co., Ltd..

Clearance details

Applicant: Acro Biomedical Co., Ltd.
Product code: Code KGN
Advisory panel: Unknown
Date received: 2023-10-02
Decision date: 2024-10-18
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.