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 |
|---|---|---|---|
| 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 |