510(k) K854255
- Device
- SPAN / AID SYRINGE
- Applicant
- SPAN-AMERICA MEDICAL SYSTEMS, INC.
- 510(k) number
- K854255
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-11-12
- Date received
- 1985-10-22
- 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
- CHARLES B MITCHELL
- Address
- P.O. Box 5231 Greenville SC US 29606 29606
FDA Registration Numbers#
- 1935627
- 3006788678
- 3010131137
- 3010291427
- 1319639
- 1518293
- 8031007
- 3008808123
- 3014819517
- 3008812560
- 3008782867
- 1043534
- 9612030
- 3010331645
- 3015225571
- 3014312726
- 3027339877
- 3005841027
- 3015724777
- 3022699058
- 3002763532
- 3015060216
- 1417485
- 3007193283
- 3019269298
- 3004024955
- 3035111606
- 3005987567
- 3007441619
- 2320767
- 1644312
- 3014262693
- 1724474
- 3013700547
- 3010221586
- 3009551627
- 3017654330
- 3030171742
- 2320762
- 3008496303
- 8010674
- 3008412416
- 3014680149
- 9614033
- 9611594
- 3010419931
- 3044026004
- 9615588
- 3030201489
- 3004082685
- 3007392007
- 3004519921
- 3027338968
- 3009249481
- 3015142721
- 1000113657
- 3010147274
- 3018326554
- 1419937
- 3008868758
- 1722458
- 3025432964
- 9610921
- 1000307092
- 3007384659
- 3010462274
- 9616157
- 1226146
- 3010175289
- 1819470
- 1019003
- 2518902
- 3012102437
- 3012116434
- 3006948745
- 3004431266
- 3015054258
- 1423929
- 3015859709
Source Documents#
510(k) summary PDF not indicated by FDA
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