Product code FIE
- Device name
- Needle, Fistula
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5540
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253469 | Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Sa... | Mozarc Medical Us, LLC | 2026-08-06 |
| K251877 | JMS CAVEO A.V. Fistula Needle Set | JMS North America Corporation | 2025-08-15 |
| K213015 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2022-04-08 |
| K171505 | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) | Dimesol, Inc. | 2018-05-17 |
| K163025 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017-07-20 |
| K151017 | JMS Harmony A.V. Fistula Needle Set | JMS North America Corporation | 2015-05-13 |
| K131950 | ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET | Summit International Medical Technologies, Inc. | 2015-01-16 |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) | JMS North America Corporation | 2014-12-23 |
| K134019 | MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO | Nxstage Medical, Inc. | 2014-09-11 |
| K112734 | APLAN A.V. FISTULA NEEDLE SET | Aplan Well Enterprise Co., Ltd. | 2012-04-24 |
| K112178 | JMS APHERESIS NEEDLE SET WINGEATER(R) V2 | JMS North America Corporation | 2011-10-27 |
| K111948 | WINGEATER V2 | JMS North America Corporation | 2011-10-24 |
| K110157 | SYSLOC MINI V3 | JMS North America Corporation | 2011-02-11 |
| K100520 | NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER | Nipro Medical Corporation | 2010-03-17 |
| K093637 | JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 | Jms North America Corp. | 2010-02-09 |
| K093985 | NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE | Nipro Medical Corp. | 2010-01-22 |
| K082882 | A.V. FISTULA BLUNT NEEDLE SET | Jms North America Corp. | 2009-01-21 |
| K062953 | MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE | Medisystems Corp. | 2007-02-12 |
| K063368 | NIPRO BIOHOLE NEEDLE | Nipro Medical Corp. | 2007-02-05 |
| K063721 | NIPRO SAFETOUCH II GAMMA | Nipro Medical Corp. | 2007-01-12 |
| K052267 | SUPERCATH V | Togo Medikit Co., Ltd. | 2006-10-27 |
| K051814 | JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET | Jms North America Corp. | 2005-08-04 |
| K040247 | PLUME SAFETY AVF NEEDLE | Jms North America Corp. | 2004-03-03 |
| K023162 | FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS | Fresenius Medical Care | 2003-03-20 |
| K013384 | SHARGHP A.V. FISTULA NEEDLE SET | Shargh Pharmaceutical Co., Inc. | 2002-01-07 |
| K013037 | EXCEL A.V FISUTAL NEEDLE SET | Exelint Intl. Co. | 2001-12-07 |
| K002352 | JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE | Jms Co., Ltd. | 2001-09-06 |
| K003123 | RENAX A.V. FISTULA NEEDLE SETS | Sunder Biomedical Tech. Co., Ltd. | 2001-05-04 |
| K002813 | NIPRO SAFETOUCH SAFETY FISTULA NEEDLE | Nipro Medical Corp. | 2000-11-21 |
| K001496 | A.V. FISTULA NEEDLE | Exelint International, Co. | 2000-08-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08888483005086 | JMS A.V. FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005215 | JMS ROTATING HUB A.V.FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005208 | JMS ROTATING HUB A.V.FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005192 | JMS A.V.FISTULA NEEDLE SET (SINGLE TYPE) | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005185 | JMS A.V.FISTULA NEEDLE SET (SINGLE TYPE) | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005178 | JMS A.V.FISTULA NEEDLE SET (SINGLE TYPE) | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005161 | JMS A.V.FISTULA NEEDLE SET (SINGLE TYPE) | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005123 | JMS A.V. FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005116 | JMS A.V. FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005109 | JMS A.V. FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005093 | JMS A.V. FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005079 | JMS A.V. FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005062 | JMS A.V. FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005055 | JMS A.V.FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005222 | JMS ROTATING HUB A.V.FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005239 | JMS WINGEATER A.V.FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005246 | JMS WINGEATER A.V.FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005253 | JMS WINGEATER A.V.FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005260 | JMS WINGEATER A.V.FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005277 | JMS WINGEATER A.V.FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 08888483005284 | JMS WINGEATER A.V.FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-09-23 |
| 00842289100732 | Medisystems OneSite dual lumen buttonhole needle with steripick | MEDISYSTEMS CORPORATION | 2016-09-16 |
| 00842289100794 | Medisystems OneSite dual lumen buttonhole needle with steripick | MEDISYSTEMS CORPORATION | 2016-09-16 |
| 00842289100787 | Medisystems OneSite dual lumen needle with masterguard | MEDISYSTEMS CORPORATION | 2016-09-16 |
| 00842289100770 | Medisystems OneSite dual lumen buttonhole needle with steripick | MEDISYSTEMS CORPORATION | 2016-09-16 |
| 00842289100763 | Medisystems OneSite dual lumen needle with masterguard | MEDISYSTEMS CORPORATION | 2016-09-16 |
| 00842289100756 | Medisystems OneSite dual lumen buttonhole needle with steripick | MEDISYSTEMS CORPORATION | 2016-09-16 |
| 00842289100749 | Medisystems OneSite dual lumen needle with masterguard | MEDISYSTEMS CORPORATION | 2016-09-16 |
| 00842289100725 | Medisystems OneSite dual lumen needle with masterguard | MEDISYSTEMS CORPORATION | 2016-09-16 |
| 08888483005291 | JMS WINGEATER A.V.FISTULA NEEDLE SET | JMS SINGAPORE PTE LTD | 2016-08-25 |