Name: Predicase
Price: 199 USD

K-number	K240407
Device name	ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor
Applicant	Stryker Endoscopy
Product code	MBI
Device class	Class II
Decision date	Mar 7, 2024
Decision	Substantially Equivalent
Regulation	888.3040

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 →

ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor

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