Retroarc Retropubic Sling System
FDA 510(k) K132655 · American Medical Systems, Inc.
510(k) numberK132655
Submission
- Device name
- Retroarc Retropubic Sling System
- Applicant
- American Medical Systems, Inc.
Minnetonka, MN, US - Received
- August 26, 2013
- Decision date
- November 20, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Retroarc Retropubic Sling System cleared by the FDA?
Retroarc Retropubic Sling System (K132655) received a 510(k) decision of Substantially Equivalent on November 20, 2013, 86 days after the submission was received.
What is the product code of K132655?
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.