FDA 510(k)

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

K-Number: K111118 · 2011-07-01

Decision Date2011-07-01

Product CodeOTP

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems. It received FDA 510(k) clearance on 2011-07-01 under 510(k) number K111118. The device is classified under product code OTP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE?

AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE is a medical device that received FDA 510(k) clearance on 2011-07-01. The listed applicant is American Medical Systems. The 510(k) number is K111118.

When did AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE receive FDA 510(k) clearance?

AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE received FDA 510(k) clearance on 2011-07-01, under 510(k) number K111118.

Who is the listed applicant for AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE?

The FDA 510(k) record lists American Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE?

The FDA product code for AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE is OTP.

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Other records listing American Medical Systems as applicant

K131229SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS K121805AMS LARGE PORE POLYPROPHLENE MESH K121641MINIARC PRO SINGLE-INCISION SLING SYSTEM K121612ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION K120870GREENLIGHT MOXY FIBER OPTIC K100746FIBER ONE

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Related Devices (Code: OTP)

K122459PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEMBoston Scientific Corporation K121612ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATIONAmerican Medical Systems K112842AMS ELEVATE PCAmerican Medical Systems, Inc.K103426LITE PELVIC FLOOR REPAIR KITSBoston Scientific Corp K112386EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMColoplast Corp.K102815SURELIFT PROLAPSE SYSTEMNeomedic International

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.