Name: Predicase
Price: 199 USD

K-number	K240527
Device name	HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
Applicant	Devicor Medical Products, Inc.
Product code	NEU
Device class	Class II
Decision date	Jul 10, 2024
Decision	Substantially Equivalent
Regulation	878.4300

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 →

HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)

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

HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)