A.V. Fistula Needle Set (#361)
FDA 510(k) K771495 · Sorensen Research
510(k) numberK771495
Submission
- Device name
- A.V. Fistula Needle Set (#361)
- Applicant
- Sorensen Research
Mchenry, IL, US - Received
- August 5, 1977
- Decision date
- August 16, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K833674 | Accurate Measurement Device Kg-AmdGCX · Traditional | 01/25/1984SE |
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| K833096 | Transducer Dome DS106DRS · Traditional | 11/03/1983SE |
| K833095 | Transducer Dome SD105DRS · Traditional | 11/03/1983SE |
| K833094 | Transducer Dome SD104DRS · Traditional | 11/03/1983SE |
| K832957 | Flow-Directed Heparin Coated ThermodilDYG · Traditional | 09/29/1983SE |
| K831506 | Disp. Transducer W/Monitoring Kit TransDRS · Traditional | 08/12/1983SE |
| K831939 | Tall Floor Stand TFS-01GCX · Traditional | 07/19/1983SE |
| K831505 | Thoracic Gauge #TG-60 -Vacuum RegulatorKDP · Traditional | 07/12/1983SE |
| K820706 | Waterless Seal & Vacuum RegulatorKDP · Traditional | 04/09/1982SE |
Questions and answers
When was A.V. Fistula Needle Set (#361) cleared by the FDA?
A.V. Fistula Needle Set (#361) (K771495) received a 510(k) decision of Substantially Equivalent on August 16, 1977, 11 days after the submission was received.
What is the product code of K771495?
The FDA product code is FIE – Needle, Fistula, a Class II (moderate risk) device regulated under 21 CFR 876.5540.