FDA 510(k)

ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION

K-Number: K121612 · 2012-07-20

Decision Date2012-07-20

Product CodeOTP

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION 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 2012-07-20 under 510(k) number K121612. 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 ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION?

ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION is a medical device that received FDA 510(k) clearance on 2012-07-20. The listed applicant is American Medical Systems. The 510(k) number is K121612.

When did ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION receive FDA 510(k) clearance?

ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION received FDA 510(k) clearance on 2012-07-20, under 510(k) number K121612.

Who is the listed applicant for ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION?

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 ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION?

The FDA product code for ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION 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 K120870GREENLIGHT MOXY FIBER OPTIC K111118AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE K100746FIBER ONE

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Related Devices (Code: OTP)

K122459PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEMBoston Scientific Corporation 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 K111118AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITEAmerican Medical Systems

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.