510(k) K874579
- Device
- COEUR CONTROL SYRINGE
- Applicant
- COEUR LABORATORIES, INC.
- 510(k) number
- K874579
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-01-19
- Date received
- 1987-11-06
- 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#
- Contact
- S DENSMORE
- Address
- 5301 Depature Dr. Raleigh NC US 27604 27604
FDA Registration Numbers#
- 3010667733
- 3025603301
- 3010515547
- 3003152976
- 3034669683
- 1518293
- 3006795797
- 1920898
- 2245304
- 3015727296
- 3015724777
- 9680602
- 1047843
- 9613304
- 1724474
- 3010432890
- 3036722184
- 3010370554
- 3003902955
- 3012329552
- 9681835
- 3008812241
- 3004024955
- 3014421917
- 3006498370
- 1420054
- 3017907716
- 3013421458
- 1832816
- 3014615644
- 3009039068
- 2649614
- 3010026090
- 3011230048
- 3022699058
- 3031259044
- 3027338968
- 3020460367
- 3010291427
- 2030598
- 3012448339
- 3009888344
- 3011137372
- 3015231789
- 1219205
- 3038294399
- 1055236
- 1647137
- 1222747
- 9680615
- 3021336182
- 3010864832
- 3005841027
- 3009493875
- 3011500374
- 3007441619
- 3003681915
- 1319660
- 3043709866
- 3029755538
- 3030447506
- 3008496303
- 3003974574
- 3035785623
- 3010512490
- 1000307092
- 9616848
- 3030089798
- 3036756245
- 3008522639
- 1644312
- 3019004087
- 1226544
- 3003477135
- 2032098
- 3002763532
- 1937141
- 9616088
- 3009595577
- 3008789114
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K250733 | 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. | 2025-07-03 |
Legacy Summary#
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FDA Review#
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