GRAFTSITE— 510(k) K173110

Substantially Equivalent

Summit Medical , Ltd.

FDA 510(k) clearance K173110 for GRAFTSITE, Substantially Equivalent on 2018-05-18. Applicant: Summit Medical , Ltd..

Clearance details

Applicant: Summit Medical , Ltd.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 2017-09-29
Decision date: 2018-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bourton On The Water, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSP

product code BSP

Death: 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.