Atlas FDA

FBK

89 FDA 510(k) clearances · Product code

86 daysmedian time to decision
254 days90th percentile
89clearances measured

FDA profile

Official device name
Endoscopic Injection Needle, Gastroenterology-Urology
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
FDA definition
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
Adverse events (MAUDE)
2021: 34 · 2022: 80 · 2023: 60 · 2024: 94 · 2025: 84 · 2026: 41
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Injection Needle (K260262)Mirco-Tech (Nanjing) Co., Ltd.2026-05-29
InjecSURE Injection System (K253598)Carbon Medical Technologies, Inc.2026-03-31
Disposable Endoscopic Injection Needles (K252021)Changzhou New Med Micro-Medtech Co., Ltd.2025-12-02
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) (K252247)Olympus Medical Systems Corporation2025-10-16
EzVu Visual Vasopressor injector (EV-19) (K241595)Veol Medical Technologies Pvt , Ltd.2025-02-27
Endoscopic Injection Needles (K240675)Promisemed Hangzhou Meditech Co., Ltd.2024-10-04
injeTAK Adjustable Tip Needle (DIS199; DIS201) (K241523)Laborie Medical Technologies, Corp.2024-08-27
Disposable Injection Needles (K232200)Ningbo Xinwell Medical Technology Co., Ltd.2024-04-12
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) (K232826)Steris2024-03-08
Disposable Endoscope Injection Needles (K232442)Zhejiang Soudon Medical Technology Co., Ltd.2023-11-09
Disposable Injection Needle AF series (K230925)Alton (Shanghai) Medical Instruments Co., Ltd.2023-09-27
Sclerotherapy & Endoscopic Needles (K222006)G-Flex Europe Sprl2023-04-03
CORE-INJECTOR (K221054)Incore Co., Ltd.2022-12-21
LiNA OperaScope Needle (K221085)Lina Medical Aps2022-09-02
Disposable Endoscope Injection Needle (K220292)Yangzhou Fartley Medical Instrument Technology Co., Ltd.2022-08-19
Injection Needle (K213914)Jiangsu Vedkang Medical Science and Technology Co., Ltd.2022-07-29
Endoscopic Injection Needle (K213239)Beijing Zksk Technology Co., Ltd.2022-06-02
Sclerotherapy Needle (K212668)Zhejiang Chuangxiang Medical Technology Co., Ltd.2022-02-23
Single Use Injection Needle (K210917)Anrei Medical (Hangzhou) Co., Ltd.2021-05-28
Single Use Injector (K192498)Olympus Medical Systems Corp.2020-04-28
Disposable Sclerotherapy Needle (K190032)Hangzhou AGS MedTech Co., Ltd.2020-02-27
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) (K190829)Wilson-Cook Medical Inc./Cook Endoscopy2019-12-19
Clear-Jet Injection Catheter (K181690)Finemedix Co., Ltd.2018-12-21
Repris Bladder Injection System (K180214)Uro-1, Inc.2018-05-03
Endoscopic Injection Needle (K172227)Carbon Medical Technologies, Inc.2017-08-23
Williams Cystoscopic Injection Needle (K171602)Cook Incorporated2017-07-28
Interject Injection Therapy Needle Catheter (K171454)Boston Scientific Corporation2017-07-07
Single Use Injector NM600/610 (K153625)Olympus Medical Systems Corp.2016-02-12
EndoChoice Select Injection Needle (K151475)Endochoice, Inc.2016-02-08
iSnare system-Lariat (K152035)United States Endoscopy Group, Inc.2015-10-15
Injection Needle (K150434)Micro-Tech (Nanjing) Co., Ltd.2015-06-02
DISPOSABLE INJECTION NEEDLE (K142144)Wilson Instruments (Shanghai) Company Limited2015-01-15
BIOMARC COAXIAL NEEDLE (K133148)Carbon Medical Technologies, Inc.2014-05-13
INJECTION NEEDLE (K132065)Endochoice, Inc.2014-01-17
UROPLASTY RIGID ENDOSCPIC NEEDLES (K121337)Uroplasty, Inc.2012-08-03
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE (K113634)Cook Ireland, Ltd.2012-02-14
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K (K111495)Wilson-Cook Medical, Inc.2011-07-19
ERBELIFT HAND PUMP AND FLEXIBLE PROBE (K092090)Byrne Medical, Inc.2009-11-30
LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP (K090830)Laborie Medical Technologies, Ltd.2009-07-21
UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 (K091391)Uroplasty, Inc.2009-06-30
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 (K090217)Coloplast A/S2009-04-23
INJEKT FILIFORM INJECTION NEEDLE (K082319)Cook Urological, Inc.2008-09-25
INJECTRA INJECTION NEEDLE (K061222)Medi-Globe Corp.2006-07-03
N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 (K043383)Physion, Inc.2005-10-27
UROPLASTY RIGID ENDOSCOPIC NEEDLE (K051905)Uroplasty, Inc.2005-08-29
TEGRESS IMPLANT NEEDLE (K050688)C.R. Bard, Inc.2005-04-06
ENTERYX INJECTION CATHETER (K042882)Boston Scientific Corp2004-11-09
CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE (K042615)Carbon Medical Technologies, Inc.2004-11-05
VARICES NEEDLE (K031238)Scandimed. A.S.2004-10-04
CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE (K030451)Carbon Medical Technologies, Inc.2003-04-30
COOK INJECTION NEEDLE (K022484)Cook Urological, Inc.2002-10-25
ENTERYX INJECTOR (K013712)Enteric Medical Technologies2002-05-31
VARICES INJECTION NEEDLE (K012977)Endo-Therapeutics, Inc.2001-11-02
OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 (K011484)Olympus Optical Co., Ltd.2001-08-10
HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES (K010448)Horizons Intl. Corp.2001-05-16
ENTERIC INJECTION CATHETER WITH IRRIGATION (K002778)Enteric Medical Technologies, Inc.2000-11-22
ADVANCED UROSCIENCE INNERSHEATH (K002573)Advanced Uroscience, Inc.2000-11-16
ADVANCED UROSCIENCE INJECTION NEEDLE (K002323)Advanced Uroscience, Inc.2000-07-31
GENYX FLEXIBLE INJECTION NEEEDLE (K001146)Geny Medical, Inc.2000-06-30
DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE (K000646)Enteric Medical Technologies2000-04-13
GENYX MEDICAL INJECTION NEEDLE (K990996)Genyx Medical, Inc.1999-06-18
INJECTION NEEDLE PROBE/DEVICE-TUNIS (K983765)Ximed/Prosure/Injectx1998-12-11
ADVANCED UROSCIENCE INJECTION NEEDLE (K982890)Advanced Uroscience, Inc.1998-10-26
NEEDLE CATHETER (K961846)Boston Scientific Corp1996-07-15
MARTECH ENDOSCOPIC INJECTION NEEDLE (K960519)Martech Medical Products, Inc.1996-05-01
GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES (K955558)Medi-Globe Corp.1996-02-29
WANG TRANSENDOSCOPIC ASPIRATION NEEDLE (K954519)Mill-Rose Laboratory1995-12-22
RIZA-RIBE NEEDLE (K953441)R-Med, Inc.1995-08-18
INJECTION NEEDLE (K953338)Boston Scientific Corp1995-08-02
MIST ENDOSCOPIC NEEDLES (K951648)Mist, Inc.1995-05-12
KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS (K950976)KARL STORZ Endoscopy-America, Inc.1995-03-21
WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE (K941305)Wilson-Cook Medical, Inc.1994-06-02
BARD ENDOSCOPIC INJECTION SYSTEM (K933815)C.R. Bard, Inc.1993-12-01
COLONOSCOPIC INJECTION NEEDLE, C-323/C-325 (K921800)Mill-Rose Laboratory1993-02-08
NEEDLE (K924102)United States Endoscopy Group, Inc.1992-11-25
SCLEROTHERAPY NEEDLE (K914496)Surgitek Medical Engineering Corp.1991-12-05
WILSON-COOK ASPIRATION HANDLE (K903668)Wilson-Cook Medical, Inc.1990-10-15
NM INJECTION NEEDLES (K902736)Olympus Corp.1990-08-24
TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE (K901437)Telemed Systems, Inc.1990-06-18
PORGES SCLEROTHERAPY NEEDLES (K896424)Porges Corp.1990-01-26
WILTEK VARICES INJECTION NEEDLE (K894868)Wiltek Medical, Inc.1989-12-21
TRANSENDOSCOPIC ASPIRATION NEEDLE (K883093)Endovations1988-12-08
WASHING/INJECTION NEEDLE (K872060)Endovations1987-07-21
WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE (K865086)Van-Tec, Inc.1987-03-10
TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS (K855176)Urologic Surgical Devices Corp.1986-05-13
VARICES INJECTOR (K851952)Wilson-Cook Medical, Inc.1985-07-26
INJECTION NEEDLE (K834403)Bobbs Medical, Inc.1984-02-04
ENDOSCOPIC INJECTION NEEDLE (K820973)Mill-Rose Laboratory1982-04-16
VANCE CYSTOSCOPIC (K812057)Vance Products, Inc.1981-07-31

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Every clearance here is in the API, with alerts when new ones post.