Forcyte Autograft Harvest Kit— 510(k) K243407

Substantially Equivalent

Forcyte Medical, LLC

FDA 510(k) clearance K243407 for Forcyte Autograft Harvest Kit, Substantially Equivalent on 2025-07-29. Applicant: Forcyte Medical, LLC.

Clearance details

Applicant: Forcyte Medical, LLC
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2024-11-01
Decision date: 2025-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.