510(k) Report

Devices descending from K212635

2 later devices reach Sofjec through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241856Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd.20241—
+2K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd.20260—