Name: Predicase
Price: 199 USD

K-number	K171825
Device name	Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument
Applicant	Hunan Handlike Minimally Invasive Surgery Co., Ltd.
Product code	GEI
Device class	Class II
Decision date	Feb 13, 2018
Decision	Substantially Equivalent
Regulation	—

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 →

Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument

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