MiroTract Wound Matrix— 510(k) K231614

Substantially Equivalent

Reprise Biomedical, Inc.

FDA 510(k) clearance K231614 for MiroTract Wound Matrix, Substantially Equivalent on 2023-12-13. Applicant: Reprise Biomedical, Inc..

Clearance details

Applicant: Reprise Biomedical, Inc.
Product code: Code KGN
Advisory panel: Unknown
Date received: 2023-06-02
Decision date: 2023-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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.