510(k) K230925

Device: Disposable Injection Needle AF series
Applicant: Alton (Shanghai) Medical Instruments Co., Ltd.
510(k) number: K230925
Product code: FBK
Decision: Substantially Equivalent (SESE)
Decision date: 2023-09-27
Date received: 2023-04-03
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: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Vivian Li
Address: #24 Bldg. Jinshao Rd.1688.Baoshan District Shanghai CN 200949 200949

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

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
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
K213239	Endoscopic Injection Needle	Beijing Zksk Technology Co., Ltd.	2022-06-02