Miniarc Pro Single-Incision Sling System
FDA 510(k) K121641 · American Medical Systems
510(k) numberK121641
Submission
- Device name
- Miniarc Pro Single-Incision Sling System
- Applicant
- American Medical Systems
Minnetonka, MN, US - Received
- June 4, 2012
- Decision date
- September 7, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PAH – Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…PAH · Traditional | Coloplast Corp. | 10/18/2024SE |
| K221874 | Altis Single Incision Sling SystemPAH · Special | Coloplast A/S | 02/15/2023SE |
| K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling…PAH · Traditional | Caldera Medical, Inc. | 02/07/2020SE |
| K121562 | Altis Single Incision Cling SystemPAH · Traditional | Coloplast A/S | 11/05/2012SE |
| K123179 | Ajust Helical Adjustable Single-Incision SlingPAH · Special | C.R. Bard, Inc. | 11/02/2012SE |
| K110420 | Ophira Mini Sling SystemPAH · Traditional | Promedon S.A | 05/08/2012SE |
| K103418 | Desara MiniPAH · Traditional | Caldera Medical, Inc. | 11/30/2011SE |
| K100807 | Miniarc Precise Single-Incision Sling System Model: 720181, 720191PAH · Traditional | American Medical Systems, Inc. | 06/07/2010SE |
| K092607 | Ajust Adjustable Single Incision SlingPAH · Traditional | C.R. Bard, Inc. | 11/20/2009SE |
| K091180 | Minitape Urethral SlingPAH · Special | Mpathy Medical Devices, Ltd. | 07/14/2009SE |
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| K132655 | Retroarc Retropubic Sling SystemOTN · Traditional | 11/20/2013SE |
| K121805 | Ams Large Pore Polyprophlene MeshOTO · Traditional | 10/16/2012SE |
| K121612 | Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationOTP · Special | 07/20/2012SE |
| K120870 | Greenlight Moxy Fiber OpticGEX · Special | 06/15/2012SE |
| K112842 | Ams Elevate PCOTP · Special | 10/25/2011SE |
| K111118 | Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair System…OTP · Special | 07/01/2011SE |
| K100746 | Fiber OneGEX · Traditional | 06/11/2010SE |
| K100807 | Miniarc Precise Single-Incision Sling System Model: 720181, 720191PAH · Traditional | 06/07/2010SE |
Questions and answers
When was Miniarc Pro Single-Incision Sling System cleared by the FDA?
Miniarc Pro Single-Incision Sling System (K121641) received a 510(k) decision of Substantially Equivalent on September 7, 2012, 95 days after the submission was received.
What is the product code of K121641?
The FDA product code is PAH – Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling, a Class II (moderate risk) device regulated under 21 CFR 878.3300.