Surgisis Sling
FDA 510(k) K992159 · Cook Biotech, Inc.
510(k) numberK992159
Submission
- Device name
- Surgisis Sling
- Applicant
- Cook Biotech, Inc.
West Lafayette, IN, US - Received
- June 25, 1999
- Decision date
- September 23, 1999
- 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 |
| K020654 | Stratasis Sling KitPAG · Traditional | Cook Biotech, Inc. | 04/09/2002SE |
| K993459 | Modification to Brennen Biosynthetic Surgical Mesh MatrixPAG · Special | Advanced Uroscience, Inc. | 11/05/1999SE |
| K982403 | Brennen Biosynthetic Surgical Mesh MatrixPAG · Traditional | Brennen Medical, Inc. | 09/22/1998SE |
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| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…OXN · Traditional | 12/27/2019SE |
| K171817 | Biodesign Diaphragmatic Hernia GraftFTM · Traditional | 03/13/2018SE |
| K162934 | Biodesign Parastomal Hernia Repair GraftFTM · Traditional | 07/10/2017SE |
| K170016 | Biodesign Fistula PlugFTM · Traditional | 06/21/2017SE |
| K170945 | Biodesign Staple Line ReinforcementOXE · Special | 04/28/2017SE |
| K161762 | DynaMatrix/Dynamatrix PlusNPL · Special | 01/13/2017SE |
| K162741 | AxoGuard Nerve ConnectorJXI · Special | 10/31/2016SE |
| K160136 | Flowable Wound MatrixKGN · Traditional | 09/28/2016SE |
Questions and answers
When was Surgisis Sling cleared by the FDA?
Surgisis Sling (K992159) received a 510(k) decision of Substantially Equivalent on September 23, 1999, 90 days after the submission was received.
What is the product code of K992159?
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.