Supris Retropubic Sling System
FDA 510(k) K111233 · Coloplast A/S
510(k) numberK111233
Submission
- Device name
- Supris Retropubic Sling System
- Applicant
- Coloplast A/S
Plymouth, MN, US - Received
- May 2, 2011
- Decision date
- June 24, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OTN – Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
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Questions and answers
When was Supris Retropubic Sling System cleared by the FDA?
Supris Retropubic Sling System (K111233) received a 510(k) decision of Substantially Equivalent on June 24, 2011, 53 days after the submission was received.
What is the product code of K111233?
The FDA product code is OTN – Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.