BioStamp nPoint— 510(k) K173510

Substantially Equivalent

Mc10, Inc.

FDA 510(k) clearance K173510 for BioStamp nPoint, Substantially Equivalent on 2018-05-08. Applicant: Mc10, Inc..

Clearance details

Applicant: Mc10, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2017-11-13
Decision date: 2018-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.