Non-Coring Needle
FDA 510(k) K961088 · Arrow Intl., Inc.
510(k) numberK961088
Submission
- Device name
- Non-Coring Needle
- Applicant
- Arrow Intl., Inc.
Walpole, MA, US - Received
- March 19, 1996
- Decision date
- July 2, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…FMI · Special | Hh Global Technology, Inc. | 08/10/2026SE |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…FMI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 08/07/2026SE |
| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | CMT Health PTE., Ltd. | 07/15/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 06/10/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
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| K071491 | Arrow International, Inc., Surgical DrapesKKX · Traditional | 10/10/2007SE |
| K071998 | Arrow Echogenic Introducer Needle ComponentFMI · Special | 09/26/2007SE |
| K071111 | Non-Absorbable Silk SutureGAP · Traditional | 07/17/2007SE |
| K060309 | Autocat Intra-Aortic Balloon Pump SeriesDSP · Special | 04/06/2006SE |
| K042126 | PiccLJS · Special | 08/27/2004SESU |
| K041153 | Sharpsaway II Locking Disposable CupFMI · Traditional | 07/12/2004SE |
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| K040802 | Hemosonic 200HEMODYNAMIC MonitorDPN · Special | 04/28/2004SE |
Questions and answers
When was Non-Coring Needle cleared by the FDA?
Non-Coring Needle (K961088) received a 510(k) decision of Substantially Equivalent on July 2, 1996, 105 days after the submission was received.
What is the product code of K961088?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.