Back to free search
Home / Search / K121612

ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION

American Medical Systems · Class III · Cleared Jul 20, 2012

K-numberK121612
Device nameELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
ApplicantAmerican Medical Systems
Product codeOTP
Device classClass III
Decision dateJul 20, 2012
DecisionSubstantially Equivalent
Regulation884.5980
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 →

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

14-day free trial. No setup. Cancel anytime.

Start free trial →
Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →