510(k) K000747
- Device
- UNIVEC TWO PIECE SYRINGE
- Applicant
- UNIVEC, INC.
- 510(k) number
- K000747
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-06-08
- Date received
- 2000-03-07
- Regulation
- 880.5860
- Classification name
- Syringe, Piston
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- S. LEVINSON
- Address
- 22 Dubon Ct. Farmingdale NY US 11735 11735
FDA Registration Numbers#
- 3014570560
- 3023851856
- 3020899789
- 3007017524
- 3002579136
- 1320894
- 3010432890
- 3006950086
- 9612152
- 3011137372
- 3015967359
- 3015727296
- 1043534
- 9610921
- 3025603301
- 3015042030
- 3016443334
- 3013700547
- 3012809732
- 3034676720
- 3013404959
- 3003310007
- 3008808123
- 3009756153
- 2032521
- 1721504
- 3043226252
- 3003902955
- 3017208642
- 3010377171
- 2244771
- 3007895168
- 1064371
- 3005669815
- 1000113657
- 3042370483
- 1225112
- 3029328631
- 1220246
- 3031788372
- 2320762
- 9615588
- 1219205
- 1720929
- 8010130
- 3004756837
- 3009249481
- 3009077131
- 3008727519
- 9681538
- 3012944064
- 3005448067
- 3013764800
- 3006371704
- 3044026004
- 9680222
- 3030201489
- 3004161147
- 3010830834
- 3000247873
- 3015724777
- 3017636737
- 3013561817
- 3016685880
- 3004605321
- 1423537
- 1450662
- 8041145
- 3021226419
- 1722458
- 3004111573
- 1037885
- 1000484830
- 3008272066
- 1055236
- 3003704957
- 3030447506
- 2011171
- 3012494290
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