Data / Medical devices / United States / Gilero, Inc

Gilero, Inc: FDA-registered device maker in Pittsboro, NC, United States, 1 510(k) clearance

Name: Gilero, Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Gilero, Inc is registered with the FDA (registration 3016733629) in Pittsboro, NC, United States. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 6, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016733629
Address: 158 Credle Street, Pittsboro, NC, United States, 27312
Owner or operator: Gilero, Inc (10053703)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: January 3, 2017
Registered through: 2026
Brand names listed: Bone Basket, Face Shield, Specimen Basket, Speed Torque

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Contract manufacturer	accessdata.fda.gov
Clamp, Vascular	DXC	2	Contract manufacturer	accessdata.fda.gov
Container, I.V.	KPE	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Intravenous Catheter Force-Activated Separation Device.	QOI	2	Contract manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Contract manufacturer	accessdata.fda.gov
Probe, Rectal, Non-Powered	EXX	1	Contract manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Contract manufacturer	accessdata.fda.gov
Trap, Sterile Specimen	BYZ	2	Contract manufacturer	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Contract manufacturer	accessdata.fda.gov
Vapocoolant Device	MLY	U	Contract manufacturer	accessdata.fda.gov
Ventilator, Non-Continuous (Respirator)	BZD	2	Contract manufacturer	accessdata.fda.gov
Wire, Guide, Catheter, Exempt	PTL	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 6, 2021	K201936	SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL	KPE	Substantially Equivalent	Gilero, LLC	accessdata.fda.gov

Compare with other makers

Updated May 6, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.