Piccolo Medical, Inc. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
PM2 System with ECGuide Connector510(k)Nov 17, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Nov 17, 2025
PM2+ System and SmartPICC Stylet510(k)May 29, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	May 29, 2025
PM2 System and ECGuide Connector510(k)Sep 8, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Sep 8, 2024
Piccolo Medical SmartPICC System510(k)Jan 22, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jan 22, 2021