Ajust Helical Adjustable Single-Incision Sling
FDA 510(k) K123179 · C.R. Bard, Inc.
510(k) numberK123179
Submission
- Device name
- Ajust Helical Adjustable Single-Incision Sling
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- October 9, 2012
- Decision date
- November 2, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K091180 | Minitape Urethral SlingPAH · Special | Mpathy Medical Devices, Ltd. | 07/14/2009SE |
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Questions and answers
When was Ajust Helical Adjustable Single-Incision Sling cleared by the FDA?
Ajust Helical Adjustable Single-Incision Sling (K123179) received a 510(k) decision of Substantially Equivalent on November 2, 2012, 24 days after the submission was received.
What is the product code of K123179?
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.