Name: Predicase
Price: 199 USD

K-number	K212920
Device name	Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
Applicant	Shandong Weigao Group Medical Polymer Co., Ltd.
Product code	FMF
Device class	Class II
Decision date	Mar 11, 2022
Decision	Substantially Equivalent
Regulation	880.5860

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use

Everything you need for a 510(k) submission. Nothing you don't.