FDA.reportPublic FDA data

510(k) K251877

Device
JMS CAVEO A.V. Fistula Needle Set
Applicant
JMS North America Corporation
510(k) number
K251877
Product code
FIE
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-15
Date received
2025-06-18
Regulation
876.5540
Classification name
Needle, Fistula
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Sho Hososki
Address
22320 Foothill Blvd. Suite 350 Hayward CA US 94541 94541

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FIE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.2022-04-08
K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)Dimesol, Inc.2018-05-17
K163025DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.2017-07-20
K151017JMS Harmony A.V. Fistula Needle SetJMS North America Corporation2015-05-13
K131950ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SETSummit International Medical Technologies, Inc.2015-01-16
K142564JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)JMS North America Corporation2014-12-23
K134019MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTONxstage Medical, Inc.2014-09-11
K112734APLAN A.V. FISTULA NEEDLE SETAplan Well Enterprise Co., Ltd.2012-04-24
K112178JMS APHERESIS NEEDLE SET WINGEATER(R) V2JMS North America Corporation2011-10-27
K111948WINGEATER V2JMS North America Corporation2011-10-24
K110157SYSLOC MINI V3JMS North America Corporation2011-02-11
K100520NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVERNipro Medical Corporation2010-03-17
K093637JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300Jms North America Corp.2010-02-09
K093985NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLENipro Medical Corp.2010-01-22
K082882A.V. FISTULA BLUNT NEEDLE SETJms North America Corp.2009-01-21