Stratasis Sling Kit
FDA 510(k) K020654 · Cook Biotech, Inc.
510(k) numberK020654
Submission
- Device name
- Stratasis Sling Kit
- Applicant
- Cook Biotech, Inc.
West Lafayette, IN, US - Received
- February 28, 2002
- Decision date
- April 9, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PAG – Mesh, Surgical, Non-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
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Other 510(k)s with product code PAG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K090688 | Cook Urological GraftPAG · Traditional | Cook Biotech, Inc. | 07/10/2009SE |
| K050445 | Ams Collagen Dermal MatrixPAG · Traditional | American Medical Systems, Inc. | 06/17/2005SE |
| K042949 | Pelvilace Transobturator Biourethral Support System (Pelvilace to System)PAG · Traditional | C.R. Bard, Inc. | 11/09/2004SE |
| K031295 | Bard Innerlace Biourethral Support SystemPAG · Traditional | C.R. Bard, Inc. | 05/15/2003SE |
| K030460 | Modification to Brennen Biosynthetic Surgical Mesh MatrixPAG · Special | Brennen Medical, Inc. | 03/07/2003SE |
| K993459 | Modification to Brennen Biosynthetic Surgical Mesh MatrixPAG · Special | Advanced Uroscience, Inc. | 11/05/1999SE |
| K992159 | Surgisis SlingPAG · Traditional | Cook Biotech, Inc. | 09/23/1999SE |
| K982403 | Brennen Biosynthetic Surgical Mesh MatrixPAG · Traditional | Brennen Medical, Inc. | 09/22/1998SE |
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| K161762 | DynaMatrix/Dynamatrix PlusNPL · Special | 01/13/2017SE |
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Questions and answers
When was Stratasis Sling Kit cleared by the FDA?
Stratasis Sling Kit (K020654) received a 510(k) decision of Substantially Equivalent on April 9, 2002, 40 days after the submission was received.
What is the product code of K020654?
The FDA product code is PAG – Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.