Open Bore Syringe
FDA 510(k) K041344 · Isotis NV
510(k) numberK041344
Submission
- Device name
- Open Bore Syringe
- Applicant
- Isotis NV
Bilthoven, NL - Received
- May 20, 2004
- Decision date
- July 16, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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| 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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| K031813 | Ossatura DentalLYC · Traditional | 08/20/2004SE |
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| K010840 | SynplugLZN · Special | 04/20/2001SE |
| K000587 | Shuttle StopLZN · Traditional | 05/04/2000SE |
Questions and answers
When was Open Bore Syringe cleared by the FDA?
Open Bore Syringe (K041344) received a 510(k) decision of Substantially Equivalent on July 16, 2004, 57 days after the submission was received.
What is the product code of K041344?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.