A.V. Fistula Needle
FDA 510(k) K001496 · Exelint International, Co.
510(k) numberK001496
Submission
- Device name
- A.V. Fistula Needle
- Applicant
- Exelint International, Co.
Los Angeles, CA, US - Received
- May 15, 2000
- Decision date
- August 1, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FIE – Needle, Fistula
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FIE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253469 | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus…FIE · Traditional | Mozarc Medical Us, LLC | 08/06/2026SE |
| K251877 | JMS CAVEO A.V. Fistula Needle SetFIE · Traditional | JMS North America Corporation | 08/15/2025SE |
| K213015 | DORA Disposable A.V. Fistula Needle SetsFIE · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 04/08/2022SE |
| K171505 | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV…FIE · Traditional | Dimesol, Inc. | 05/17/2018SE |
| K163025 | DORA Disposable A.V. Fistula Needle SetsFIE · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 07/20/2017SE |
| K151017 | JMS Harmony A.V. Fistula Needle SetFIE · Special | JMS North America Corporation | 05/13/2015SE |
| K131950 | Angel Tip Safety Intravascular Needle SetFIE · Traditional | Summit International Medical Technologies, Inc. | 01/16/2015SE |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)FIE · Special | JMS North America Corporation | 12/23/2014SE |
| K134019 | Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle Protector…FIE · Traditional | Nxstage Medical, Inc. | 09/11/2014SE |
| K112734 | Aplan A.V. Fistula Needle SetFIE · Traditional | Aplan Well Enterprise Co., Ltd. | 04/24/2012SE |
More from Aplan Well Enterprise Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe…FMF · Traditional | 12/12/2025SE |
| K152183 | EXELINT SecureTouch Safety Hypodermic NeedleFMI · Traditional | 11/02/2015SE |
| K101309 | Exelint Aluminum Hub Blunt NeedlesLHI · Traditional | 10/20/2010SE |
| K020189 | Exel Butterfly Scalp Vein SetFPA · Traditional | 03/27/2003SE |
| K010197 | Exel Secure Touch Safety (P.S.V.) Scalp Vein SetFPA · Traditional | 05/14/2001SE |
| K003627 | Exel Secure Touch Safety A.V. Fistula Needle SetFMI · Traditional | 02/08/2001SE |
Questions and answers
When was A.V. Fistula Needle cleared by the FDA?
A.V. Fistula Needle (K001496) received a 510(k) decision of Substantially Equivalent on August 1, 2000, 78 days after the submission was received.
What is the product code of K001496?
The FDA product code is FIE – Needle, Fistula, a Class II (moderate risk) device regulated under 21 CFR 876.5540.