Name: Predicase
Price: 199 USD

K-number	K211021
Device name	Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
Applicant	Micro-Tech (Nanjing) Co., Ltd.
Product code	FGE
Device class	Class II
Decision date	May 6, 2022
Decision	Substantially Equivalent
Regulation	876.5010

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 Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible

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