FDA.reportPublic FDA data

CLEAR GUIDE MEDICAL

Matched from indexed company URL: Clear Guide Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30113966873011396687CLEAR GUIDE MEDICAL1N2026-01-013600 Clipper Mill Rd Ste 400 Baltimore MD US 21211

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B201CGOHM0Clear Guide Optical Head - The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.+1 (443) 267-7661support@clearguidemedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1787961777437710K843719SINGLE WALL INTRODUCER NEEDLEDYB1984-10-18
1787961525317255K234030Clear Guide SCENERGYJAK2024-01-17
1787961501267775K201898Clear Guide SCENERGYJAK2020-07-31
1787961722913709K201188Clear Guide SCENERGYJAK2020-09-30
1787961183993038K171677Clear Guide SCENERGYJAK2017-12-08
1787961611182138K153004Clear Guide SCENERGYJAK2016-02-12
1787961848722460K141806CLEAR GUIDE ONEIYO2014-09-19
1787961596323212
1787961960201773

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAK52024-01-17
IYO12014-09-19
DYB11984-10-18

PMN#

GUDID#

Clear Guide TP Access Posts - The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device constitutes 3 pairs of posts (T, M, S) as a replacement for Clear Guide TP Access Tool (CG-PAT).

CLEAR GUIDE MEDICAL, INC.

2025-01-10

Clear Guide TP Access Frame - The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is a guide frame replacement for the Clear Guide TP Access Tool (CG-PAT).

CLEAR GUIDE MEDICAL, INC.

2025-01-10

Clear Guide SCENERGY TP - The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR.The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide Optical Head platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting, in patients of sufficient size (at least 25 kg).

CLEAR GUIDE MEDICAL, INC.

2025-01-10

Clear Guide CORE - The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.

CLEAR GUIDE MEDICAL, INC.

2022-10-06