510(k) Report

Devices descending from K051783

15 later devices reach Artsana Pen Needles, Artsana Injection Needles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151311Safe Block Pen NeedleArtsana S.P.A201611—
+1K110606MV Intradermic Needles; Magic Needle; Magic NeedleM.V.S.R.L.20112—
+2K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.20260—
+2K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20179—
+2K161255meso-relle (AAL34, AAL36, AM30G)Biotekne Srl20171—
+3K242632Verifine® Pen NeedlesPromisemed Hangzhou Meditech Co., Ltd.20240—
+3K230070MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM®…Promamedical, Inc.20230—
+3K210059Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20211—
+3K210065Verifine Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20210—
+3K193422Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc.20211—
+3K202681Promisemed Covered Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—
+3K191853Dual-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20191—
+4K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…Sandstone Medical (Suzhou), Inc.20260—
+4K222739Disposable Insulin Pen NeedleHantech Medical Device Co., Ltd.20230—
+4K202682Promisemed Triple Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—