Endoscopic Injection Needle, Gastroenterology-Urology
FDA product code FBK · 84 cleared devices
Class 2
Gastroenterology, Urology
- Regulation
- 21 CFR 876.1500
- Review panel
- GU
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1981-07-31 – 2026-05-29
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
FBK
2026-05-29
FBK
2026-03-31
InjecSURE Injection System
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FBK
2025-12-02
Disposable Endoscopic Injection Needles
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FBK
2025-10-16
Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)
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FBK
2025-02-27
EzVu Visual Vasopressor injector (EV-19)
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FBK
2024-10-04
Endoscopic Injection Needles
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FBK
2024-08-27
injeTAK Adjustable Tip Needle (DIS199; DIS201)
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FBK
2024-04-12
Disposable Injection Needles
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FBK
2024-03-08
Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)
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FBK
2023-11-09
Disposable Endoscope Injection Needles
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FBK
2023-09-27
Disposable Injection Needle AF series
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FBK
2023-04-03
Sclerotherapy & Endoscopic Needles
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FBK
2022-12-21
CORE-INJECTOR
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FBK
2022-09-02
LiNA OperaScope Needle
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FBK
2022-08-19
Disposable Endoscope Injection Needle
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FBK
2022-07-29
Injection Needle
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FBK
2022-06-02
Endoscopic Injection Needle
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FBK
2022-02-23
Sclerotherapy Needle
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FBK
2021-05-28
Single Use Injection Needle
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FBK
2020-04-28
Single Use Injector
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FBK
2020-02-27
Disposable Sclerotherapy Needle
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FBK
2019-12-19
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
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FBK
2018-12-21
Clear-Jet Injection Catheter
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FBK
2018-05-03
Repris Bladder Injection System
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FBK
2017-08-23
Endoscopic Injection Needle
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FBK
2017-07-28
Williams Cystoscopic Injection Needle
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FBK
2017-07-07
Interject Injection Therapy Needle Catheter
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FBK
2016-02-12
Single Use Injector NM600/610
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FBK
2016-02-08
EndoChoice Select Injection Needle
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FBK
2012-08-03
UROPLASTY RIGID ENDOSCPIC NEEDLES
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FBK
2012-02-14
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE
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FBK
2011-07-19
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
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FBK
2009-11-30
ERBELIFT HAND PUMP AND FLEXIBLE PROBE
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FBK
2009-07-21
LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP
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FBK
2009-06-30
UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
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FBK
2009-04-23
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
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FBK
2008-09-25
INJEKT FILIFORM INJECTION NEEDLE
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FBK
2006-07-03
INJECTRA INJECTION NEEDLE
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FBK
2005-10-27
N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110
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FBK
2005-08-29
UROPLASTY RIGID ENDOSCOPIC NEEDLE
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FBK
2005-04-06
TEGRESS IMPLANT NEEDLE
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FBK
2004-11-09
ENTERYX INJECTION CATHETER
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FBK
2004-11-05
CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE
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FBK
2004-10-04
VARICES NEEDLE
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FBK
2003-04-30
CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE
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FBK
2002-10-25
COOK INJECTION NEEDLE
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FBK
2002-05-31
ENTERYX INJECTOR
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FBK
2001-11-02
VARICES INJECTION NEEDLE
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FBK
2001-08-10
OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1
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FBK
2001-05-16
HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
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FBK
2000-11-22
ENTERIC INJECTION CATHETER WITH IRRIGATION
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FBK
2000-11-16
ADVANCED UROSCIENCE INNERSHEATH
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FBK
2000-07-31
ADVANCED UROSCIENCE INJECTION NEEDLE
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FBK
2000-06-30
GENYX FLEXIBLE INJECTION NEEEDLE
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FBK
2000-04-13
DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
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FBK
1999-06-18
GENYX MEDICAL INJECTION NEEDLE
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FBK
1998-12-11
INJECTION NEEDLE PROBE/DEVICE-TUNIS
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FBK
1998-10-26
ADVANCED UROSCIENCE INJECTION NEEDLE
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FBK
1996-07-15
NEEDLE CATHETER
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FBK
1996-05-01
MARTECH ENDOSCOPIC INJECTION NEEDLE
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FBK
1996-02-29
GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES
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FBK
1995-12-22
WANG TRANSENDOSCOPIC ASPIRATION NEEDLE
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FBK
1995-08-18
RIZA-RIBE NEEDLE
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FBK
1995-08-02
INJECTION NEEDLE
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FBK
1995-05-12
MIST ENDOSCOPIC NEEDLES
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FBK
1995-03-21
KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS
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FBK
1994-06-02
WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE
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FBK
1993-12-01
BARD ENDOSCOPIC INJECTION SYSTEM
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FBK
1993-02-08
COLONOSCOPIC INJECTION NEEDLE, C-323/C-325
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FBK
1992-11-25
NEEDLE
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FBK
1991-12-05
SCLEROTHERAPY NEEDLE
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FBK
1990-10-15
WILSON-COOK ASPIRATION HANDLE
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FBK
1990-08-24
NM INJECTION NEEDLES
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FBK
1990-06-18
TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE
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FBK
1990-01-26
PORGES SCLEROTHERAPY NEEDLES
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FBK
1989-12-21
WILTEK VARICES INJECTION NEEDLE
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FBK
1988-12-08
TRANSENDOSCOPIC ASPIRATION NEEDLE
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FBK
1987-07-21
WASHING/INJECTION NEEDLE
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FBK
1987-03-10
WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE
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FBK
1986-05-13
TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS
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FBK
1985-07-26
VARICES INJECTOR
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FBK
1984-02-04
INJECTION NEEDLE
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FBK
1982-04-16
ENDOSCOPIC INJECTION NEEDLE
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FBK
1981-07-31
VANCE CYSTOSCOPIC
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