510(k) K841566
- Device
- HESUNG DISPOSABLE SYRINGE
- Applicant
- AMKOR TRADING CO.
- 510(k) number
- K841566
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-07-17
- Date received
- 1984-04-17
- Regulation
- 880.5860
- Classification name
- Syringe, Piston
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3004142400
- 2523676
- 3007344957
- 1422634
- 3003902955
- 3012341425
- 9617544
- 1518293
- 3010621964
- 3005798905
- 3012302888
- 3008272066
- 2249062
- 3034669683
- 3008868758
- 3010384323
- 3038356900
- 3015485283
- 3013561817
- 1423662
- 1035907
- 3010864832
- 3005246939
- 2032227
- 3027534634
- 3012329552
- 3010419931
- 3012050423
- 3016904853
- 3004054016
- 3014159736
- 3020138744
- 3023174629
- 3007193505
- 3012039263
- 1056553
- 8041187
- 3019004087
- 3010370554
- 3031233007
- 1054241
- 1036836
- 3009888344
- 3010026090
- 3006371704
- 1647137
- 1018470
- 1819470
- 3014315664
- 3016851379
- 3011500374
- 9612152
- 1644312
- 8010026
- 3002807090
- 1832816
- 9610048
- 3008770691
- 3008412416
- 8021764
- 3010041511
- 2183744
- 2025816
- 8021538
- 3006788678
- 3014004349
- 3019807891
- 3045857302
- 3013556777
- 3009756153
- 2649614
- 3010291427
- 1224960
- 3012421607
- 3015151147
- 3013023255
- 3024508819
- 2030624
- 3021336182
- 3018125942
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260208 | Ultra-Fine™ SAFETY Insulin Syringe | embecta Medical II, LLC | 2026-07-13 |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | 2026-06-18 |
| K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. | 2026-06-12 |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | 2026-05-21 |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | 2026-04-17 |
| K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | 2026-02-23 |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 2025-12-22 |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | 2025-12-17 |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | 2025-12-12 |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | 2025-11-04 |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | 2025-10-15 |
| K243660 | Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | Cardinalhealth | 2025-08-22 |
| K251350 | BD Plastipak™ Syringe | Becton, Dickinson and Company | 2025-07-29 |
| K252033 | Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle | CMT Health PTE., Ltd. | 2025-07-25 |
Legacy Summary#
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FDA Review#
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