Name: Predicase
Price: 199 USD

K-number	K030472
Device name	MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
Applicant	Ethicon Endo-Surgery, Inc.
Product code	KNW
Device class	Class II
Decision date	Oct 9, 2003
Decision	Substantially Equivalent
Regulation	876.1075

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 →

MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM

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