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I-Stop Mid-Urethral Sling, Models IS-1000, IS-2000, IS-3000, IS-4000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K052175

by Uroplasty, Inc.

Identifiers

510(k) Number
K052175 FDA 510(k)
FDA Product Code
OTN FDA 510(k)
Models / Variants
Is-1000 FDA 510(k)
Is-2000 FDA 510(k)
Is-3000 FDA 510(k)
Is-4000 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3300 FDA 510(k)
Regulation Number
878.3300 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The I-Stop Mid-Urethral Sling is a synthetic surgical mesh device designed for the treatment of female stress urinary incontinence. It consists of non-resorbable polypropylene mesh, polyethylene clips, stainless steel implantation needles, and polycarbonate needle handles, intended for retropubic or transobturator placement to support the urethra and restore continence.

The device is supplied sterile and intended for single-use in surgical settings. It is classified under product code OTN as a Class II device under FDA regulations, with clearance granted as substantially equivalent. Models IS-1000, IS-2000, IS-3000, and IS-4000 are authorized for use in urogynecologic procedures, adhering to standard surgical sterility and handling protocols.

Frequently asked questions

What is the I-Stop Mid-Urethral Sling IS-3000 used for?

The I-Stop Mid-Urethral Sling IS-3000 is designed to treat female stress urinary incontinence by providing urethral support. The non-resorbable polypropylene mesh is placed either retropubically or transobturatorly to restore continence in patients experiencing involuntary urine leakage during physical activity or stress.

How is the I-Stop Mid-Urethral Sling supplied and prepared for use?

The device is supplied sterile and intended for single-use in surgical settings. It includes polypropylene mesh, polyethylene clips, stainless steel implantation needles, and polycarbonate needle handles. Prior to use, the sterile packaging must be opened in a controlled surgical environment, adhering to standard aseptic techniques.

Is the I-Stop Mid-Urethral Sling reusable or intended for single-use?

The I-Stop Mid-Urethral Sling is explicitly intended for single-use only. Its components, including the mesh and needles, are not designed for reprocessing or reuse to maintain sterility and performance standards. Discard any unused portions after opening the sterile packaging.

What models of the I-Stop Mid-Urethral Sling are available, and how do they differ?

The I-Stop Mid-Urethral Sling is available in four models: IS-1000, IS-2000, IS-3000, and IS-4000. While the exact differences between models are not specified in the provided data, these variations likely cater to different patient anatomies or surgical preferences. Consult the manufacturer’s instructions for specific model indications and sizing guidance.

How should the I-Stop Mid-Urethral Sling be stored before use?

The device must be stored in its original, unopened sterile packaging in a clean, dry environment protected from direct sunlight, extreme temperatures, and moisture. Ensure the packaging remains intact to preserve sterility. Follow the manufacturer’s storage instructions to maintain device integrity until immediate preoperative use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: I-stop Mid-urethral Sling, Models Is-1000, Is-2000, Is-3000, Is-4000, K052175 FDA 510(k) - I-STOP MID-URETHRAL SLING | Uroplasty, Inc., I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Uroplasty, Inc.

Sources (1)

  • FDA 510(k) K052175 24 fields · synced Oct 1, 2026