Product Code: FBK
FDA class 2
21 CFR 876.1500
Endoscopic Injection Needle, Gastroenterology-Urology
Gastroenterology, Urology
The Endoscopic Injection Needle for Gastroenterology-Urology (product code FBK) is a needle device inserted through an endoscope to inject solutions, gas, or implantable materials into gastrointestinal or genitourinary tissue. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.
510(k)s
85
FEI Numbers
92
Registration Numbers
92
Unique Applicants
67
Years Active
44
Basic Information
- Product Code
- FBK
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
Definition
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 85 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241595 | EzVu Visual Vasopressor injector (EV-19) | Feb 27, 2025 | Substantially Equivalent | Veol Medical Technologies Pvt Ltd. |
| K240675 | Endoscopic Injection Needles | Oct 04, 2024 | Substantially Equivalent | Promisemed Hangzhou Meditech Co., Ltd. |
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | Aug 27, 2024 | Substantially Equivalent | Laborie Medical Technologies Corp. |
| K232200 | Disposable Injection Needles | Apr 12, 2024 | Substantially Equivalent | Ningbo Xinwell Medical Technology Co., Ltd |
| K232826 | 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) | Mar 08, 2024 | Substantially Equivalent | STERIS |
| K232442 | Disposable Endoscope Injection Needles | Nov 09, 2023 | Substantially Equivalent | Zhejiang Soudon Medical Technology Co.,Ltd |
| K230925 | Disposable Injection Needle AF series | Sep 27, 2023 | Substantially Equivalent | Alton (Shanghai) Medical Instruments Co. Ltd |
| K222006 | Sclerotherapy & Endoscopic Needles | Apr 03, 2023 | Substantially Equivalent | G-Flex Europe SPRL |
| K221054 | CORE-INJECTOR | Dec 21, 2022 | Substantially Equivalent | Incore Co., Ltd. |
| K221085 | LiNA OperaScope Needle | Sep 02, 2022 | Substantially Equivalent | LiNA Medical ApS |
| K220292 | Disposable Endoscope Injection Needle | Aug 19, 2022 | Substantially Equivalent | Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
| K213914 | Injection Needle | Jul 29, 2022 | Substantially Equivalent | Jiangsu Vedkang Medical Science and Technology Co.,Ltd |
| K213239 | Endoscopic Injection Needle | Jun 02, 2022 | Substantially Equivalent | Beijing ZKSK Technology Co.,Ltd |
| K212668 | Sclerotherapy Needle | Feb 23, 2022 | Substantially Equivalent | Zhejiang Chuangxiang Medical Technology Co., LTD. |
| K210917 | Single Use Injection Needle | May 28, 2021 | Substantially Equivalent | Anrei Medical (Hangzhou) Co., Ltd. |
| K192498 | Single Use Injector | Apr 28, 2020 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K190032 | Disposable Sclerotherapy Needle | Feb 27, 2020 | Substantially Equivalent | Hangzhou AGS MedTech CO., Ltd |
| K190829 | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) | Dec 19, 2019 | Substantially Equivalent | Wilson-Cook Medical, Inc. / Cook Endoscopy |
| K181690 | Clear-Jet Injection Catheter | Dec 21, 2018 | Substantially Equivalent | Finemedix Co. Ltd. |
| K180214 | Repris Bladder Injection System | May 03, 2018 | Substantially Equivalent | URO-1, Inc. |
| K172227 | Endoscopic Injection Needle | Aug 23, 2017 | Substantially Equivalent | Carbon Medical Technologies, Inc. |
| K171602 | Williams Cystoscopic Injection Needle | Jul 28, 2017 | Substantially Equivalent | Cook Incorporated |
| K171454 | Interject Injection Therapy Needle Catheter | Jul 07, 2017 | Substantially Equivalent | Boston Scientific Corporation |
| K153625 | Single Use Injector NM600/610 | Feb 12, 2016 | Substantially Equivalent | OLYMPUS MEDICAL SYSTEMS CORP. |
| K151475 | EndoChoice Select Injection Needle | Feb 08, 2016 | Substantially Equivalent | ENDOCHOICE, INC. |
| K152035 | iSnare system-Lariat | Oct 15, 2015 | Substantially Equivalent | United States Endoscopy Group, Inc |
| K150434 | Injection Needle | Jun 02, 2015 | Substantially Equivalent | Micro-Tech (Nanjing) CO., Ltd. |
| K142144 | DISPOSABLE INJECTION NEEDLE | Jan 15, 2015 | Substantially Equivalent | WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED |
| K133148 | BIOMARC COAXIAL NEEDLE | May 13, 2014 | Substantially Equivalent | CARBON MEDICAL TECHNOLOGIES, INC. |
| K132065 | INJECTION NEEDLE | Jan 17, 2014 | Substantially Equivalent | ENDOCHOICE, INC. |
| K121337 | UROPLASTY RIGID ENDOSCPIC NEEDLES | Aug 03, 2012 | Substantially Equivalent | UROPLASTY, INC. |
| K113634 | INJEKT CYSTO FLEXIBLE INJECTION NEEDLE | Feb 14, 2012 | Substantially Equivalent | COOK IRELAND LTD |
| K111495 | COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K | Jul 19, 2011 | Substantially Equivalent | WILSON-COOK MEDICAL INC. |
| K092090 | ERBELIFT HAND PUMP AND FLEXIBLE PROBE | Nov 30, 2009 | Substantially Equivalent | BYRNE MEDICAL INC. |
| K090830 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP | Jul 21, 2009 | Substantially Equivalent | LABORIE MEDICAL TECHNOLOGIES, LTD. |
| K091391 | UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 | Jun 30, 2009 | Substantially Equivalent | UROPLASTY, INC. |
| K090217 | BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 | Apr 23, 2009 | Substantially Equivalent | COLOPLAST A/S |
| K082319 | INJEKT FILIFORM INJECTION NEEDLE | Sep 25, 2008 | Substantially Equivalent | COOK UROLOGICAL, INC. |
| K061222 | INJECTRA INJECTION NEEDLE | Jul 03, 2006 | Substantially Equivalent | MEDI-GLOBE CORP. |
| K043383 | N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 | Oct 27, 2005 | Substantially Equivalent | PHYSION, INC. |
| K051905 | UROPLASTY RIGID ENDOSCOPIC NEEDLE | Aug 29, 2005 | Substantially Equivalent | UROPLASTY, INC. |
| K050688 | TEGRESS IMPLANT NEEDLE | Apr 06, 2005 | Substantially Equivalent | C.R. BARD, INC. |
| K042882 | ENTERYX INJECTION CATHETER | Nov 09, 2004 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K042615 | CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE | Nov 05, 2004 | Substantially Equivalent | CARBON MEDICAL TECHNOLOGIES, INC. |
| K031238 | VARICES NEEDLE | Oct 04, 2004 | Substantially Equivalent | SCANDIMED. A.S. |
| K030451 | CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE | Apr 30, 2003 | Substantially Equivalent | CARBON MEDICAL TECHNOLOGIES, INC. |
| K022484 | COOK INJECTION NEEDLE | Oct 25, 2002 | Substantially Equivalent | COOK UROLOGICAL, INC. |
| K013712 | ENTERYX INJECTOR | May 31, 2002 | Substantially Equivalent | ENTERIC MEDICAL TECHNOLOGIES |
| K012977 | VARICES INJECTION NEEDLE | Nov 02, 2001 | Substantially Equivalent | ENDO-THERAPEUTICS, INC. |
| K011484 | OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 | Aug 10, 2001 | Substantially Equivalent | OLYMPUS OPTICAL CO., LTD. |
| K010448 | HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES | May 16, 2001 | Substantially Equivalent | HORIZONS INTL. CORP. |
| K002778 | ENTERIC INJECTION CATHETER WITH IRRIGATION | Nov 22, 2000 | Substantially Equivalent | ENTERIC MEDICAL TECHNOLOGIES, INC. |
| K002573 | ADVANCED UROSCIENCE INNERSHEATH | Nov 16, 2000 | Substantially Equivalent | ADVANCED UROSCIENCE, INC. |
| K002323 | ADVANCED UROSCIENCE INJECTION NEEDLE | Jul 31, 2000 | Substantially Equivalent | ADVANCED UROSCIENCE, INC. |
| K001146 | GENYX FLEXIBLE INJECTION NEEEDLE | Jun 30, 2000 | Substantially Equivalent | GENY MEDICAL, INC. |
| K000646 | DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE | Apr 13, 2000 | Substantially Equivalent | ENTERIC MEDICAL TECHNOLOGIES |
| K990996 | GENYX MEDICAL INJECTION NEEDLE | Jun 18, 1999 | Substantially Equivalent | GENYX MEDICAL, INC. |
| K983765 | INJECTION NEEDLE PROBE/DEVICE-TUNIS | Dec 11, 1998 | Substantially Equivalent | XIMED/PROSURE/INJECTX |
| K982890 | ADVANCED UROSCIENCE INJECTION NEEDLE | Oct 26, 1998 | Substantially Equivalent | ADVANCED UROSCIENCE, INC. |
| K961846 | NEEDLE CATHETER | Jul 15, 1996 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K960519 | MARTECH ENDOSCOPIC INJECTION NEEDLE | May 01, 1996 | Substantially Equivalent | MARTECH MEDICAL PRODUCTS, INC. |
| K955558 | GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES | Feb 29, 1996 | Substantially Equivalent | MEDI-GLOBE CORP. |
| K954519 | WANG TRANSENDOSCOPIC ASPIRATION NEEDLE | Dec 22, 1995 | Substantially Equivalent | MILL-ROSE LABORATORY |
| K953441 | RIZA-RIBE NEEDLE | Aug 18, 1995 | Substantially Equivalent | R-MED, INC. |
| K953338 | INJECTION NEEDLE | Aug 02, 1995 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K951648 | MIST ENDOSCOPIC NEEDLES | May 12, 1995 | Substantially Equivalent | MIST, INC. |
| K950976 | KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS | Mar 21, 1995 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K941305 | WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE | Jun 02, 1994 | Substantially Equivalent | WILSON-COOK MEDICAL, INC. |
| K933815 | BARD ENDOSCOPIC INJECTION SYSTEM | Dec 01, 1993 | Substantially Equivalent | C.R. BARD, INC. |
| K921800 | COLONOSCOPIC INJECTION NEEDLE, C-323/C-325 | Feb 08, 1993 | Substantially Equivalent | MILL-ROSE LABORATORY |
| K924102 | NEEDLE | Nov 25, 1992 | Substantially Equivalent | UNITED STATES ENDOSCOPY GROUP, INC. |
| K914496 | SCLEROTHERAPY NEEDLE | Dec 05, 1991 | Substantially Equivalent | SURGITEK MEDICAL ENGINEERING CORP. |
| K903668 | WILSON-COOK ASPIRATION HANDLE | Oct 15, 1990 | Substantially Equivalent | WILSON-COOK MEDICAL, INC. |
| K902736 | NM INJECTION NEEDLES | Aug 24, 1990 | Substantially Equivalent | OLYMPUS CORP. |
| K901437 | TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE | Jun 18, 1990 | Substantially Equivalent | TELEMED SYSTEMS, INC. |
| K896424 | PORGES SCLEROTHERAPY NEEDLES | Jan 26, 1990 | Substantially Equivalent | PORGES CORP. |
| K894868 | WILTEK VARICES INJECTION NEEDLE | Dec 21, 1989 | Substantially Equivalent | WILTEK MEDICAL, INC. |
| K883093 | TRANSENDOSCOPIC ASPIRATION NEEDLE | Dec 08, 1988 | Substantially Equivalent | ENDOVATIONS |
| K872060 | WASHING/INJECTION NEEDLE | Jul 21, 1987 | Substantially Equivalent | ENDOVATIONS |
| K865086 | WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE | Mar 10, 1987 | Substantially Equivalent | VAN-TEC, INC. |
| K855176 | TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS | May 13, 1986 | Substantially Equivalent | UROLOGIC SURGICAL DEVICES CORP. |
| K851952 | VARICES INJECTOR | Jul 26, 1985 | Substantially Equivalent | WILSON-COOK MEDICAL, INC. |
| K834403 | INJECTION NEEDLE | Feb 04, 1984 | Substantially Equivalent | BOBBS MEDICAL, INC. |
| K820973 | ENDOSCOPIC INJECTION NEEDLE | Apr 16, 1982 | Substantially Equivalent | MILL-ROSE LABORATORY |
| K812057 | VANCE CYSTOSCOPIC | Jul 31, 1981 | Substantially Equivalent | VANCE PRODUCTS, INC. |
FEI Numbers
This FDA classification entry is associated with 92 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 92 registration numbers. Click on an entry to view related FDA registrations.