510(k) K941562
- Device
- 1ML LUER-LOK SYRINGE
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K941562
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-05-26
- Date received
- 1994-04-01
- Regulation
- 880.5860
- Classification name
- Syringe, Piston
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DON A CUTSHALL
- Address
- 1 Becton Dr. Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 3003829571
- 3015859709
- 9610847
- 3027339877
- 1056186
- 1226544
- 2518902
- 1219205
- 1721504
- 3013556777
- 3010512490
- 3005813632
- 1320894
- 3010864832
- 3010419931
- 2433012
- 3036978618
- 3015550451
- 3018125942
- 3003477135
- 3022699058
- 3003589911
- 3008496303
- 3004161147
- 3003348846
- 3027242374
- 3014314985
- 3005246939
- 9610921
- 3005862821
- 3002806603
- 3012944064
- 3012116434
- 3010132111
- 3010515547
- 3016707060
- 2530154
- 3018094310
- 1043214
- 3005853033
- 3012461127
- 1530671
- 3007384659
- 1061927
- 3012039263
- 3004496829
- 1450743
- 2647898
- 3011683674
- 2025648
- 1423929
- 2029214
- 1720929
- 3008719222
- 3042158867
- 3005405146
- 3010370554
- 3004142400
- 9680602
- 3016851379
- 1423662
- 3004111573
- 3042953454
- 3015142802
- 3014312726
- 9681538
- 3011453824
- 3010026090
- 3003529145
- 3004458481
- 1319660
- 3014159736
- 3003704957
- 9612057
- 3010321647
- 3009211636
- 3005202235
- 3013160284
- 3010197239
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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases