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

Name: FDA 510(k) clearance K210949
Creator: U.S. Food and Drug Administration
Published: 2022-08-11

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.. Device class: Unclassified.

Clearance details

Applicant: Bionova Medical, Inc.
Product code: Code KGN
Device class: Unclassified
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 ↗

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More clearances from Bionova Medical, Inc.

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K243181 — Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo2024-10-31
K240298 — Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo2024-08-21
K231937 — Foundation Dermal Regeneration Scaffold (DRS) Solo2023-11-13
K123961 — SENTREX BIOSPONGE MPD2013-04-05
K112191 — HEALEX BIOSPONGE WOUND DRESSING2012-06-05

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.