FIE — Needle, Fistula Class II
FDA product code FIE covers "Needle, Fistula", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FIE
- Device Class
- Class II
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253469 | Mozarc Medical Us | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritu | Aug 6, 2026 |
| K251877 | Jms North America Corporation | JMS CAVEO A.V. Fistula Needle Set | Aug 15, 2025 |
| K213015 | Bain Medical Equipment (Guangzhou) Co | DORA Disposable A.V. Fistula Needle Sets | Apr 8, 2022 |
| K171505 | Dimesol | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposa | May 17, 2018 |
| K163025 | Bain Medical Equipment (Guangzhou) Co | DORA Disposable A.V. Fistula Needle Sets | Jul 20, 2017 |
| K151017 | Jms North America Corporation | JMS Harmony A.V. Fistula Needle Set | May 13, 2015 |
| K131950 | Summit International Medical Technologies | ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET | Jan 16, 2015 |
| K142564 | Jms North America Corporation | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle S | Dec 23, 2014 |
| K134019 | Nxstage Medical | MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECT | Sep 11, 2014 |
| K112734 | Aplan Well Enterprise Co | APLAN A.V. FISTULA NEEDLE SET | Apr 24, 2012 |
| K112178 | Jms North America Corporation | JMS APHERESIS NEEDLE SET WINGEATER(R) V2 | Oct 27, 2011 |
| K111948 | Jms North America Corporation | WINGEATER V2 | Oct 24, 2011 |
| K110157 | Jms North America Corporation | SYSLOC MINI V3 | Feb 11, 2011 |
| K100520 | Nipro Medical Corporation | NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER | Mar 17, 2010 |
| K093637 | Jms North America | JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 82 | Feb 9, 2010 |
| K093985 | Nipro Medical | NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE | Jan 22, 2010 |
| K082882 | Jms North America | A.V. FISTULA BLUNT NEEDLE SET | Jan 21, 2009 |
| K062953 | Medisystems | MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE | Feb 12, 2007 |
| K063368 | Nipro Medical | NIPRO BIOHOLE NEEDLE | Feb 5, 2007 |
| K063721 | Nipro Medical | NIPRO SAFETOUCH II GAMMA | Jan 12, 2007 |