FIE — Needle, Fistula Class II
FDA Device Classification
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 |
|---|
| K251877 | jms north america corporation | JMS CAVEO A.V. Fistula Needle Set | August 15, 2025 |
| K213015 | bain medical equipment (guangzhou) co | DORA Disposable A.V. Fistula Needle Sets | April 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 | July 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 | January 16, 2015 |
| K142564 | jms north america corporation | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle S | December 23, 2014 |
| K134019 | nxstage medical | MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECT | September 11, 2014 |
| K112734 | aplan well enterprise co | APLAN A.V. FISTULA NEEDLE SET | April 24, 2012 |
| K112178 | jms north america corporation | JMS APHERESIS NEEDLE SET WINGEATER(R) V2 | October 27, 2011 |
| K111948 | jms north america corporation | WINGEATER V2 | October 24, 2011 |
| K110157 | jms north america corporation | SYSLOC MINI V3 | February 11, 2011 |
| K100520 | nipro medical corporation | NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER | March 17, 2010 |
| K093637 | jms north america | JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 82 | February 9, 2010 |
| K093985 | nipro medical | NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE | January 22, 2010 |
| K082882 | jms north america | A.V. FISTULA BLUNT NEEDLE SET | January 21, 2009 |
| K062953 | medisystems | MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE | February 12, 2007 |
| K063368 | nipro medical | NIPRO BIOHOLE NEEDLE | February 5, 2007 |
| K063721 | nipro medical | NIPRO SAFETOUCH II GAMMA | January 12, 2007 |
| K052267 | togo medikit co | SUPERCATH V | October 27, 2006 |