Ophira Mini Sling System
by Promedon S.A. Argentina EUDAMED510(k)
510(k) K110420
Product code PAH
Overview
The Ophira Mini Sling System is a synthetic, surgical mesh device classified as a urogynecologic mini-sling for female stress urinary incontinence. Designed as a Class II medical device, it is intended for transvaginal placement to support the urethra and treat stress urinary incontinence in women.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K110420) and falls under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The system is available in multiple sizes and configurations, as indicated by the registration numbers, and is intended for use in clinical settings by healthcare professionals. No MRI safety information is specified in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK110420 | Date8 May 2012 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- PAH
- FDA applicant
- Promedon S.A
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Promedon S.A.
Questions
What is the Ophira Mini Sling System used for in clinical practice?
The Ophira Mini Sling System is designed specifically for transvaginal placement to support the urethra and treat female stress urinary incontinence. It is a synthetic surgical mesh intended for urogynecologic use, providing a minimally invasive option for women experiencing stress-related urine leakage.
How many sizes or configurations are available for the Ophira Mini Sling System, and how are they differentiated?
The Ophira Mini Sling System comes in multiple sizes and configurations, as indicated by the registration numbers (e.g., 3021632375, 3016678045, etc.). These variations allow clinicians to select the appropriate size for different patient anatomies, ensuring a tailored fit for transvaginal placement.
Is the Ophira Mini Sling System intended for single-use or reusable applications?
The Ophira Mini Sling System is explicitly intended for single-use only. It is supplied sterile to ensure patient safety and prevent cross-contamination in clinical settings.
What regulatory pathways has the Ophira Mini Sling System undergone, and which agencies have authorized its use?
The Ophira Mini Sling System has been cleared by the FDA under the 510(k) pathway (K110420) and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in Europe. These authorizations confirm its classification as a Class II medical device for urogynecologic use.
Are there any special storage requirements for the Ophira Mini Sling System before use?
While the provided data does not specify exact storage conditions, the system is supplied sterile, so it should be stored in a clean, dry environment protected from contamination until use. Clinicians should follow standard sterile packaging protocols to maintain integrity until implantation.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K110420
- EUDAMED