GeniPhys Collymer Self-Assembling Scaffold— 510(k) K250329

Substantially Equivalent

Geniphys, Inc.

FDA 510(k) clearance K250329 for GeniPhys Collymer Self-Assembling Scaffold, Substantially Equivalent on 2025-06-25. Applicant: Geniphys, Inc..

Clearance details

Applicant: Geniphys, Inc.
Product code: Code KGN
Advisory panel: Unknown
Date received: 2025-02-05
Decision date: 2025-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.