Name: Predicase
Price: 199 USD

K-number	K984220
Device name	MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
Applicant	ETHICON, Inc.
Product code	FTL
Device class	Class II
Decision date	Feb 23, 1999
Decision	Substantially Equivalent
Regulation	878.3300

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 →

MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH

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