FDA.reportPublic FDA data

General-purpose endoscopic needle, single-use

Definition
A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.
GUDID devices
1,459
Last updated
2026-07-17 21:58:54

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04953170459207Single-use Fine Needle Biopsy (FNB) DeviceOLYMPUS MEDICAL SYSTEMS CORP.NA-U210H-80192025-12-02
04953170459252Single-use Fine Needle Biopsy (FNB) DeviceOLYMPUS MEDICAL SYSTEMS CORP.NA-U210H-80222025-12-02
04953170459313Single-use Fine Needle Biopsy (FNB) DeviceOLYMPUS MEDICAL SYSTEMS CORP.NA-U210H-80252025-12-02
00191506030742Acquire™ SBOSTON SCIENTIFIC CORPORATIONM005556402024-05-16
00191506030759Acquire™ SBOSTON SCIENTIFIC CORPORATIONM005556602024-05-15
00304040003350Henry ScheinHENRY SCHEIN, INC.90011592018-09-24
00304040020371Henry ScheinHENRY SCHEIN, INC.90013642018-09-24
00350770927701Injection Needle CatheterAvanos Medical, Inc.927702019-07-27
00350770927718Injection Needle CatheterAvanos Medical, Inc.927712019-07-27
00350770927749Injection Needle CatheterAvanos Medical, Inc.927742019-07-27
00350770927756Injection Needle CatheterAvanos Medical, Inc.927752019-07-27
00350770927800Injection Needle CatheterAvanos Medical, Inc.927802019-07-27
00627825000017injeTAK Adjustable Tip Needle 35cmLaborie Medical Technologies Canada ULCDIS1992016-09-21
00627825000024injeTAK Adjustable Tip Needle 70cmLaborie Medical Technologies Canada ULCDIS2012016-09-21
00724995180836ArticulatorUS Endoscopy007118032020-04-01
00724995180843ArticulatorUS Endoscopy007118042020-04-01
00724995180850ArticulatorUS Endoscopy007118072020-04-01
00724995180867ArticulatorUS Endoscopy007118082020-04-01
00724995180874ArticulatorUS Endoscopy007118102020-04-01
00724995180881NAUS Endoscopy007118112020-04-02
00724995180898NAUS Endoscopy007118122020-04-02
00724995180904NAUS Endoscopy007118132020-04-02
00724995180911NAUS Endoscopy007118142020-04-02
00724995180928NAUS Endoscopy007118222020-04-02
00724995180935NAUS Endoscopy007118232020-04-02
00724995180942NAUS Endoscopy007118242020-04-02
00724995182885HistolockUS Endoscopy007118722020-04-02
00724995219185FastFloUS Endoscopy007118282022-11-09
00724995219192FastFloUS Endoscopy007118292022-11-09
00724995219208FastFloUS Endoscopy007118302022-11-09
00724995219215FastFloUS Endoscopy007118312022-11-09
00810339030339SAFE DENTBGSS Company Inc.A90177BK2024-05-01
00810339030360SAFE DENTBGSS Company Inc.A90179BL2024-05-01
00810339030391SAFE DENTBGSS Company Inc.A90178G2024-05-01
00810339030421SAFE DENTBGSS Company Inc.A90180P2024-05-01
00816207020174EndoTNeedleENDO-THERAPEUTICS, INC.ET13102016-09-22
00816207020945Endoscopic injection needleENDO-THERAPEUTICS, INC.SN-1623-222018-05-14
00816207021010EndoTNeedleENDO-THERAPEUTICS, INC.ET13002018-05-14
00816207021034EndoTNeedleENDO-THERAPEUTICS, INC.ET13022018-05-14
00816207021058EndoTNeedleENDO-THERAPEUTICS, INC.ET13012018-05-14
00816207021065EndoTNeedleENDO-THERAPEUTICS, INC.ET13032018-05-14
00816207021133EndoTNeedleENDO-THERAPEUTICS, INC.ET13202019-12-03
00816207021140EndoTNeedleENDO-THERAPEUTICS, INC.ET13212019-12-03
00816207021157EndoTNeedleENDO-THERAPEUTICS, INC.ET13222019-12-03
00816207021164EndoTNeedleENDO-THERAPEUTICS, INC.ET13232019-12-03
00816207021218AcuJect FlexENDO-THERAPEUTICS, INC.AJ FLEX 25 230 102019-12-03
00816207021256AcuJect FlexENDO-THERAPEUTICS, INC.AJ FLEX 23 230 102023-07-11
00816734023365EZ-JectDIVERSATEK HEALTHCARE, INC.1186-012024-07-18
00816734023372EZ-JectDIVERSATEK HEALTHCARE, INC.1186-022024-07-18
00816734023389EZ-JectDIVERSATEK HEALTHCARE, INC.1186-032024-07-18
00816734023396EZ-JectDIVERSATEK HEALTHCARE, INC.1186-042024-07-18
00816765011843ArticulatorUS Endoscopy007118032016-09-17
00816765011850ArticulatorUS Endoscopy007118042016-09-17
00816765011867ArticulatorUS Endoscopy007118072016-09-17
00816765011874ArticulatorUS Endoscopy007118082016-09-17
00816765011881ArticulatorUS Endoscopy007118102016-09-17
00816765011898NAUS Endoscopy007118112016-09-17
00816765011904NAUS Endoscopy007118122016-09-17
00816765011911NAUS Endoscopy007118132016-09-17
00816765011928NAUS Endoscopy007118142016-09-17
00816765012475NAUS Endoscopy007118222016-09-17
00816765012666NAUS Endoscopy007118232016-09-17
00816765012673NAUS Endoscopy007118242016-09-17
00816765012833HistolockUS Endoscopy007118722016-09-17
00840516136844Anodyne SurgicalPsi/Eye-Ko, Inc.50122023-08-02
00840516136851Anodyne SurgicalPsi/Eye-Ko, Inc.50122023-08-24
00850002461404InjecSURE ®Carbon Medical Technologies, Inc.890-305SS2026-04-09
00850002461435InjecSURE®Carbon Medical Technologies, Inc.890-305PS2026-04-09
00855208005162BeaconCovidien LPF-19-052019-03-07
00855208005179BeaconCovidien LPF-22-052019-03-07
00858015005943Endoscopic Injection NeedleCarbon Medical Technologies, Inc.1010872017-10-25
00886874115954FlexisionINTUITIVE SURGICAL, INC.4901022019-03-21
00886874115961FlexisionINTUITIVE SURGICAL, INC.4901032019-03-21
00886874115978FlexisionINTUITIVE SURGICAL, INC.4901042019-03-21
03600040326893BoNeeColoplast A/SNBI0702025-05-20
03600040974841BoNeeColoplast A/SNBI0352025-05-20
04052838009393Injectra, Sclero TipMedi-Globe GmbHGSN-01-19-1802019-05-15
04052838009416Injectra, ScleroTipMedi-Globe GmbHGSN-01-19-2302017-06-14
04052838009430Injectra, Sclero TipMedi-Globe GmbHGSN-02-23-1802019-05-15
04052838009454Injectra, Sclero TipMedi-Globe GmbHGSN-02-23-2302019-05-15