Data / Medical devices / United States / Clear Guide Medical

Clear Guide Medical: FDA-registered device maker in Baltimore, MD, United States, 7 510(k) clearances

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

Clear Guide Medical is registered with the FDA (registration 3011396687) in Baltimore, MD, United States. It lists 7 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 17, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3011396687
Address: 3600 Clipper Mill Rd Ste 400, Baltimore, MD, United States, 21211
Owner or operator: Clear Guide Medical (10048333)
Roles: Repackager or relabeler, Specification developer
First device listed: December 30, 2014
Registered through: 2027
Brand names listed: Clear Guide ONE, Clear Guide SCENERGY, Clear Guide SCENERGY TP, Clear Guide SteriGRID, Clear Guide TP Access Tool, Clear Guide TipTAG, Clear Guide VisiMARKER, Clear Guide VisiMARKER II and more

Devices it lists

Device	Product code	Class	Role	Source
Drape, Surgical, Exempt	PUI	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Repackager or relabeler	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
System, X-Ray, Film Marking, Radiographic	JAC	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Repackager or relabeler, Specification developer	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
January 17, 2024	K234030	Clear Guide SCENERGY	JAK	Substantially Equivalent	Clear Guide Medical	accessdata.fda.gov
September 30, 2020	K201188	Clear Guide SCENERGY	JAK	Substantially Equivalent	Clear Guide Medical	accessdata.fda.gov
July 31, 2020	K201898	Clear Guide SCENERGY	JAK	Substantially Equivalent	Clear Guide Medical	accessdata.fda.gov
December 8, 2017	K171677	Clear Guide SCENERGY	JAK	Substantially Equivalent	Clear Guide Medical	accessdata.fda.gov
February 12, 2016	K153004	Clear Guide SCENERGY	JAK	Substantially Equivalent	Clear Guide Medical	accessdata.fda.gov
September 19, 2014	K141806	CLEAR GUIDE ONE	IYO	Substantially Equivalent	Clear Guide Medical	accessdata.fda.gov
October 18, 1984	K843719	SINGLE WALL INTRODUCER NEEDLE	DYB	Substantially Equivalent	Ocean Medical Products, Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 17, 2024. 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.