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SureLift Prolapse System

by Neomedic International 510(k)

Active United States

510(k) K102815

Overview

The SureLift Prolapse System is a synthetic, transvaginally placed urogynecologic mesh device designed for the surgical treatment of pelvic organ prolapse. Classified as a Class III medical device, it is intended for use in procedures to support and reposition pelvic organs that have descended into the vaginal canal.

This system is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K102815) and falls under the regulatory category for synthetic surgical mesh (regulation number 884.5980). Storage and handling must comply with sterile surgical instrument protocols, and its use is restricted to clinical settings by trained healthcare professionals.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK102815 Date7 Jul 2011ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
OTP
Device Class
Class III
Regulation
21 CFR Part 884.5980
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Other devices from Neomedic International S.L.

  • Kim

    Class II

  • Anchorsure

    Class II

Questions

  • What types of pelvic organ prolapse conditions is the SureLift Prolapse System designed to address?

    The SureLift Prolapse System is specifically designed for surgical treatment of pelvic organ prolapse, where organs such as the bladder, uterus, or rectum have descended into the vaginal canal. It provides transvaginal support to reposition and stabilize these organs during the procedure.

  • Is the SureLift Prolapse System reusable or intended for single-use, and how should it be stored?

    The SureLift Prolapse System is supplied sterile and intended for single-use only. Storage must follow sterile surgical instrument protocols to maintain its integrity, as it is not designed for reuse or reprocessing.

  • What regulatory pathway was followed for FDA clearance of the SureLift Prolapse System, and what does that mean for its use?

    The SureLift Prolapse System received FDA clearance through a 510(k) Traditional review (K102815) under the Obstetrics/Gynecology advisory committee, with a decision of *Substantially Equivalent* (SESE). This means it was deemed comparable to a legally marketed predicate device, and its use is restricted to clinical settings by trained healthcare professionals.

  • Are there different sizes or models available for the SureLift Prolapse System, and how would I identify them?

    The SureLift Prolapse System is categorized under product code OTP (Obstetrics/Therapeutic, Pelvic Organ Prolapse) and includes multiple FEI numbers (1000121298, 1018233, 3004838863, 1048735) for regulatory tracking. While specific sizes or models aren’t detailed in the data, these identifiers may correlate to variations in mesh dimensions or configurations. Contact Neomedic International for precise sizing options.