Foundation Dermal Regeneration Scaffold (DRS) Solo— 510(k) K210949

Substantially Equivalent

Bionova Medical, Inc.

FDA 510(k) clearance K210949 for Foundation Dermal Regeneration Scaffold (DRS) Solo, Substantially Equivalent on 2022-08-11. Applicant: Bionova Medical, Inc..

Clearance details

Applicant: Bionova Medical, Inc.
Product code: Code KGN
Advisory panel: Unknown
Date received: 2021-03-30
Decision date: 2022-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Germantown, TN, 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.