510(k) K983765
- Device
- INJECTION NEEDLE PROBE/DEVICE-TUNIS
- Applicant
- XIMED/PROSURE/INJECTX
- 510(k) number
- K983765
- Product code
- FBK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-12-11
- Date received
- 1998-10-26
- Regulation
- 876.1500
- Classification name
- Endoscopic Injection Needle, Gastroenterology-urology
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ASHVIN DESAI
- Address
- 2195 Trade Zone Blvd. San Jose CA US 95131 95131
FDA Registration Numbers#
- 3008573567
- 1722746
- 3006621103
- 3011193403
- 1519132
- 3027269340
- 3009747810
- 3010288205
- 3011146996
- 3012480535
- 3025311469
- 2431166
- 3002647932
- 3035451914
- 1000121056
- 2134494
- 8010047
- 3011050570
- 3010202439
- 1047843
- 3004784537
- 3015895045
- 1018233
- 3007699067
- 1828424
- 9610711
- 3004083736
- 3004837686
- 3005580113
- 3011707784
- 1222168
- 3017448360
- 2183446
- 3010273872
- 3003790304
- 3010515547
- 3008274780
- 3004207966
- 3010419931
- 3004129994
- 3009064553
- 1825146
- 1061927
- 3015142721
- 1037905
- 1643817
- 3015972753
- 3003814961
- 2020550
- 9680809
- 1820334
- 3035434483
- 3014769442
- 3009888344
- 9680001
- 9610614
- 2246552
- 3006750742
- 3017178358
- 3005099803
- 1056129
- 1220592
- 9614641
- 3021632375
- 3021023752
- 1000393132
- 3014620201
- 3005941719
- 3013526170
- 3015042209
- 1647149
- 3013460719
- 3010188783
- 1528319
- 3012649202
- 9681260
- 3007695959
- 3011270181
- 3008797804
- 3012042439
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FBK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253598 | InjecSURE Injection System | Carbon Medical Technologies, Inc. | 2026-03-31 |
| K252021 | Disposable Endoscopic Injection Needles | Changzhou New Med Micro-Medtech Co., Ltd. | 2025-12-02 |
| K252247 | 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) | Olympus Medical Systems Corporation | 2025-10-16 |
| K241595 | EzVu Visual Vasopressor injector (EV-19) | Veol Medical Technologies Pvt , Ltd. | 2025-02-27 |
| K240675 | Endoscopic Injection Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2024-10-04 |
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | Laborie Medical Technologies, Corp. | 2024-08-27 |
| K232200 | Disposable Injection Needles | Ningbo Xinwell Medical Technology Co., Ltd. | 2024-04-12 |
| 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) | Steris | 2024-03-08 |
| K232442 | Disposable Endoscope Injection Needles | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-09 |
| K230925 | Disposable Injection Needle AF series | Alton (Shanghai) Medical Instruments Co., Ltd. | 2023-09-27 |
| K222006 | Sclerotherapy & Endoscopic Needles | G-Flex Europe Sprl | 2023-04-03 |
| K221054 | CORE-INJECTOR | Incore Co., Ltd. | 2022-12-21 |
| K221085 | LiNA OperaScope Needle | Lina Medical Aps | 2022-09-02 |
| K220292 | Disposable Endoscope Injection Needle | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-08-19 |
| K213914 | Injection Needle | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022-07-29 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases