510(k) K231165

Device: Shina Syringe; Shina Safety Syringe
Applicant: Shina Med Corporation
510(k) number: K231165
Product code: MEG
Decision: Substantially Equivalent (SESE)
Decision date: 2023-10-27
Date received: 2023-04-25
Regulation: 880.5860
Classification name: Syringe, Antistick
Medical specialty: General Hospital
Review panel: General Hospital
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Tae Joo Ha
Address: 455-30. Bogaewonsam-Ro, Anseong-Si, Gyeonggi-Do, Republic Of Korea Anseong-Si KR 17509 17509

FDA Registration Numbers

3005670221
3012777736
3020298301
3022699058
3038356900
3005202235
1423507
3006142663
3038294399
3008307705
3003681915
3009746425
2183744
3037918935
3009742443
1915484
1035907
3023339256
3014162214
3007007790
3012809732
3020294761
3003829571
3005246939
3000126234
3015142721
3001124136
3013557562
3010131137
3004416208
1423537
3010515547
3029328631
3008789114
3012307300
3004143450
3013298431
3014662855
3002807968
3010864832
3015140199
3033536319
3004417597
3030626857
8021538
3015620563
3035111606
3002907620
3012421607
3007594734
1649518
1219611
1058584
3012646696
1213809
3010405396
3017509841
3036722184
3006973666
9616482
3004496829
3017770710
3036679495
3027338968
1417592
8040619
2183771
3034667025
1319639
3031259044
3014819517
3016685880
3015142802
3007441619
3013513377
3014456066
3024508819
3003902955
3011088743

Source Documents

510(k) summary PDF

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K221981	SafeR Syringe and SafeR Sting	Roncadelle Operations Srl	2022-12-29
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K220057	Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization	Shinva Ande Healthcare Apparatus Co., Ltd.	2022-10-07
K221073	Sterile Hypodermic Syringes for Single Use with Safety Needles	Sichuan Prius Biotechnology Co., Ltd.	2022-10-04
K220061	Safety Insulin Syringes	Berpu Medical Technology Co., Ltd.	2022-08-23
K212518	Jeesung Safety Syringe and Single Use Needles	Jeesung Medical Co., Ltd.	2022-08-18
K213077	Automatically Retractable Safety Syringe	Zhejiang Lingyang Medical Apparatus Co., Ltd.	2022-04-27
K210216	Disposable Automatically Retractable Insulin Safety Syringe	Shantou Wealy Medical Instrument Co.,Ltd	2022-03-04