PELNAC Meshed Bilayer Wound Matrix— 510(k) K213498

Substantially Equivalent

Gunze Limited

FDA 510(k) clearance K213498 for PELNAC Meshed Bilayer Wound Matrix, Substantially Equivalent on 2022-07-14. Applicant: Gunze Limited.

Clearance details

Applicant: Gunze Limited
Product code: Code KGN
Advisory panel: Unknown
Date received: 2021-11-01
Decision date: 2022-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ayabe, Kyoto, JP

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.