BD Integra Syringe
FDA 510(k) K023752 · Bd
510(k) numberK023752
Submission
- Device name
- BD Integra Syringe
- Applicant
- Bd
Franklin Lakes, NJ, US - Received
- November 8, 2002
- Decision date
- February 7, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | SurGenTec, LLC | 08/26/2026SE |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | Sol-Millennium Medical, Inc. | 08/25/2026SE |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
| K260208 | Ultra-Fine SAFETY Insulin SyringeFMF · Traditional | embecta Medical II, LLC | 07/13/2026SE |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 06/18/2026SE |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional | CMT Health PTE., Ltd. | 06/12/2026SE |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special | Hlb Lifescience Co., Ltd. | 05/21/2026SE |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
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| K180438 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitPSZ · Special | 03/20/2018SE |
| K024240 | BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and KitsJSM · Traditional | 03/26/2003SE |
| K021475 | BD Single Lumen Needle, Syringe and Blood Collection SetFMI · Traditional | 07/19/2002SE |
| K020523 | BD Bifurcated Needle, Models 301754, 301755, 301756, 301757SCL · Traditional | 03/20/2002SE |
| K011967 | BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp SyringeFOZ · Traditional | 01/23/2002SE |
Questions and answers
When was BD Integra Syringe cleared by the FDA?
BD Integra Syringe (K023752) received a 510(k) decision of Substantially Equivalent on February 7, 2003, 91 days after the submission was received.
What is the product code of K023752?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.