FDA.reportPublic FDA data

Needle guide, single-use

Definition
A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as guides for urethral injections, guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. Disposable imaging-supportive devices (e.g., ultrasound transducer cover) may be included with the device. This is a single-use device.
GUDID devices
68
Last updated
2023-06-16 08:27:22

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
20886333227284Co-Axial Introducer NeedleARGON MEDICAL DEVICES, INC.044-8992023-06-08
05060498307369Dash 6 NRFit™INTERVENE GROUP LIMITED150900022023-06-02
00841436122115Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.116529612023-05-03
00841436122122Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.115754422023-05-03
17350031350330Gangi-SoftGuard Coaxial NeedleApriomed ABG0332023-04-24
17350031350347Gangi-SoftGuard Coaxial NeedleApriomed ABG0342023-04-24
17350031350354Gangi-SoftGuard Coaxial NeedleApriomed ABG0352023-04-24
17350031350361Gangi-SoftGuard Coaxial NeedleApriomed ABG0362023-04-24
17350031350378Gangi-SoftGuard Coaxial NeedleApriomed ABG0372023-04-24
17350031350385Gangi-SoftGuard Coaxial NeedleApriomed ABG0382023-04-24
17350031350392Gangi-SoftGuard Coaxial NeedleApriomed ABG0392023-04-24
17350031350408Gangi-SoftGuard Coaxial NeedleApriomed ABG0402023-04-24
17350031350415Gangi-SoftGuard Coaxial NeedleApriomed ABG0412023-04-24
17350031350422Gangi-SoftGuard Coaxial NeedleApriomed ABG0422023-04-24
17350031350439Gangi-HydroGuard Coaxial NeedleApriomed ABG0432023-04-24
17350031350446Gangi-HydroGuard Coaxial NeedleApriomed ABG0442023-04-24
17350031350453Gangi-HydroGuard Coaxial NeedleApriomed ABG0452023-04-24
17350031350460Gangi-SoftGuard Coaxial NeedleApriomed ABG0462023-04-24
17350031350491SeeStarApriomed ABG0492023-04-24
17350031350507SeeStarApriomed ABG0502023-04-24
17350031350514SeeStarApriomed ABG0512023-04-24
17350031350521SeeStarApriomed ABG0522023-04-24
00884838103740PhilipsPhilips Ds North America LLCSentinelle, Biopsy Grid2023-02-24
00841436122559Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.644-1012023-02-04
00841436122566Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.644-1022023-02-04
05704916001667Non-implantable needle guide, single-useBK MEDICAL APSUA1353-S182022-12-07
05704916001698Non-implantable needle guide, single-useBk Medical ApSUA1353-SIP2022-12-07
00841436121989NeedleGuideCIVCO MEDICAL INSTRUMENTS CO., INC.H44901AW2022-12-07
00841436121996NeedleGuideCIVCO MEDICAL INSTRUMENTS CO., INC.H44901AX2022-12-07
00841436113601Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.676-1942022-10-28
00841436121385Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.676-2252022-10-28
00841436121392Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.115043392022-10-28
00841436121712Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.115069012022-10-28
10848340015325Ultrasound Probe Cover Biopsy Needle Guide KitADVANCE MEDICAL DESIGNS, INC.28-GG5372022-10-25
30822045001122SAM ThoraSite®SAM Medical ProductsTS200-5P-EN2022-09-01
40822045001129SAM ThoraSite®SAM Medical ProductsTS200-25P-EN2022-09-01
20886333226331Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB1810BX2022-07-26
20886333226348Co-Axial Cannula Bundle ARGON MEDICAL DEVICES, INC.MCXB1816BX2022-07-26
20886333226355Co-Axial Cannula Bundle ARGON MEDICAL DEVICES, INC.MCXB1820BX2022-07-26
20886333226362Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB1825BX2022-07-26
20886333226379Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB2010BX2022-07-26
20886333226386Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB2016BX2022-07-26
20886333226393Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB2020BX2022-07-26
20886333225891Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB1820BP2022-07-21
20886333225907Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB1610BPU2022-07-21
20886333225914Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB1615BPU2022-07-21
20886333225921Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB1810BPU2022-07-21
20886333225938Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB1815BPU2022-07-21
20886333225945Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB1820BPU2022-07-21
20886333226270Co-Axial Introducer NeedleARGON MEDICAL DEVICES, INC.MCXS1410BX2022-07-21
20886333226287Co-Axial Introducer NeedleARGON MEDICAL DEVICES, INC.MCXS1416BX2022-07-21
20886333226294Co-Axial Introducer NeedleARGON MEDICAL DEVICES, INC.MCXS1420BX2022-07-21
20886333226300Co-Axial Introducer NeedleARGON MEDICAL DEVICES, INC.MCXS1610BX2022-07-21
20886333226317Co-Axial Introducer NeedleARGON MEDICAL DEVICES, INC.MCXS1616BX2022-07-21
20886333226324Co-Axial Introducer NeedleARGON MEDICAL DEVICES, INC.MCXS1620BX2022-07-21
00886333225866Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB1615BP2022-07-20
20886333225853Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB1610BP2022-07-20
20886333225877Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB1810BP2022-07-20
20886333225884Co-Axial Cannula BundleARGON MEDICAL DEVICES, INC.MCXB1815BP2022-07-20
20886333001686Needle GuideARGON MEDICAL DEVICES, INC.LNGO1619PX2022-07-11
20886333001716Needle GuideARGON MEDICAL DEVICES, INC.LNGO2022YX2022-07-11
00886333001705Needle GuideARGON MEDICAL DEVICES, INC.LNGC14GX2022-07-07
20886333001679Needle GuideARGON MEDICAL DEVICES, INC.LNGC2022YX2022-07-07
20886333001693Needle GuideARGON MEDICAL DEVICES, INC.LNGC1619PX2022-07-07
M710ERGUIDE10102OcciGuideBIOTEX, INC.048-10002021-02-25
00884838101425InvivoPhilips Ds North America LLC453530208382021-04-10
00884838101432InvivoPhilips Ds North America LLC453530096542021-04-10
08033860016890BIOPSYBELL SRLBIOPSYBELL SRLINTRODUCER2022-06-09