FDA 510(k) clearance · back to tracker

AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

American Medical Systems cleared K111118 on 2011-07-01, decision: substantially equivalent

K-number

K111118

Sponsor

American Medical Systems

Device

AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

Class

Class III

Decision

Substantially Equivalent

Decision date

2011-07-01

Product code

OTP

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.5980

Official FDA record

Open K111118on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.