Name: Predicase
Price: 199 USD

K-number	K182217
Device name	Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use
Applicant	Ezisurg (Suzhou) Medical Co., Ltd.
Product code	GDW
Device class	Class II
Decision date	Apr 16, 2019
Decision	Substantially Equivalent
Regulation	878.4750

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 →

Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use

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