510(k) K070856
- Device
- ICU MEDICAL SINGLE-USE SYRINGE
- Applicant
- ICU MEDICAL, INC
- 510(k) number
- K070856
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-10-05
- Date received
- 2007-03-28
- Regulation
- 880.5860
- Classification name
- Syringe, Piston
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TRACY S BEST
- Address
- 4455 Atherton Dr. Salt Lake City UT US 84123 84123
FDA Registration Numbers#
- 3017654330
- 3015974593
- 3042158867
- 3020138744
- 9614279
- 3006697681
- 3023228837
- 1319639
- 3020460367
- 3031233007
- 3011683674
- 1043534
- 3011088743
- 3014004349
- 3007392007
- 1921846
- 3003681915
- 1222747
- 1225112
- 1019003
- 3016678045
- 3031259044
- 1423537
- 3038294399
- 3000268902
- 3036773433
- 3030412764
- 9680794
- 3007017524
- 3015142721
- 3003418325
- 3019004087
- 3013700547
- 1217831
- 3005798905
- 3007344957
- 8010418
- 3003974574
- 3013176080
- 3009742443
- 3002808227
- 3042971905
- 3015151147
- 1061124
- 3030626857
- 3006950086
- 3015859709
- 1819470
- 3003595336
- 3009107690
- 3010462274
- 3015724777
- 9616088
- 2025870
- 1066733
- 3004111573
- 8010130
- 3012552122
- 3004431266
- 3007384659
- 3015042030
- 2183449
- 3013160284
- 2517117
- 2649614
- 1066444
- 9611024
- 3012102437
- 3012410077
- 3012039263
- 3009328501
- 3008412416
- 3010377171
- 2650089
- 3014716786
- 1530671
- 3005448067
- 3015142802
- 3004417597
Source Documents#
Other 510(k) Records For Product Code FMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®) | SurGenTec, LLC | 2026-08-26 |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | Sol-Millennium Medical, Inc. | 2026-08-25 |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | 2026-08-14 |
| 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 |
Legacy Summary#
summary
FDA Review#
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