510(k) K223376

Device: Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)
Applicant: Cardinal Health200, LLC
510(k) number: K223376
Product code: MEG
Decision: Substantially Equivalent (SESE)
Decision date: 2023-06-21
Date received: 2022-11-04
Regulation: 880.5860
Classification name: Syringe, Antistick
Medical specialty: General Hospital
Review panel: General Hospital
Device class: 2
Clearance type: Abbreviated
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Emily Hunter
Address: 3651 Birchwood Dr. Waukegan IL US 60085 60085

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
3015528193
3012494290
1921846
3010026090
3010934635
3014312726
3010621964
3005405146
1220477
1647137
3015972753
3014315664
9613304
3017717188
3007392007
3042370483
3014747754
3010830834
3011287770
9610847
1911916
2243072
3015474594
3014570560
3012039263
3007279404
3007490412
3030525551
3004458481
3018681450
9681413
3038220293
9680794
3004425647
3007590959
3012461127
1450743
3005798905
3043226252
3010085632
3029755538
3030089798
3013187142
1920898
3008719222
9615588
3012116434
3016904853
3023228837
3012050423

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MEG

510(k)	Device	Applicant	Decision date
K252098	PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)	Methyl Co., Ltd.	2026-02-18
K250847	VaporShield	Vault Paragon Group, Inc.	2025-12-12
K230287	SaviSafe Safety Device	Suzhou Savicred Biotechnology Co., Ltd.	2023-11-21
K231165	Shina Syringe; Shina Safety Syringe	Shina Med Corporation	2023-10-27
K231907	Medline Safety Insulin and TB Syringes	Medline Industries, LP	2023-10-18
K220114	PowerPAK Syringe	Vault Paragon Group, Inc.	2023-01-25
K221981	SafeR Syringe and SafeR Sting	Roncadelle Operations Srl	2022-12-29
K222452	Disposable Automatically Retractable Safety Syringes (with detachable needle)	Shantou Wealy Medical Instrument Co.,Ltd	2022-11-23
K221247	Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle	Jiangsu Kangbao Medical Equipment Co., Ltd.	2022-11-01
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