Modification to Brennen Biosynthetic Surgical Mesh Matrix
FDA 510(k) K030460 · Brennen Medical, Inc.
510(k) numberK030460
Submission
- Device name
- Modification to Brennen Biosynthetic Surgical Mesh Matrix
- Applicant
- Brennen Medical, Inc.
St. Paul, MN, US - Received
- February 12, 2003
- Decision date
- March 7, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K992159 | Surgisis SlingPAG · Traditional | Cook Biotech, Inc. | 09/23/1999SE |
| K982403 | Brennen Biosynthetic Surgical Mesh MatrixPAG · Traditional | Brennen Medical, Inc. | 09/22/1998SE |
More from Brennen Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K113866 | Porcine Dermal Xenografts Porcine Dermal MatrixKGN · Traditional | 03/23/2012SE |
| K111436 | Porcine Surgical Mesh, Porcine Dermal MatrixFTM · Traditional | 10/14/2011SE |
| K081272 | Porcine Surgical Mesh; Dermal MatrixFTM · Traditional | 07/31/2008SE |
| K050086 | Brennen Medical Silver Glucan Wound DressingFRO · Traditional | 02/17/2006SE |
| K021835 | Brennen Medical Surgical Mesh, Glucamesh/GlucatexFTL · Traditional | 10/17/2002SE |
| K002078 | Beta Glucan Gel (Macropro Gel)MGQ · Traditional | 10/02/2000SE |
| K002077 | Glucanpro CreamMGQ · Traditional | 10/02/2000SE |
| K000519 | GlucanproMGQ · Traditional | 05/01/2000SE |
| K000518 | Macropro GelMGQ · Traditional | 05/01/2000SE |
| K982825 | Brennen Medical Beta Glucan GelMGQ · Traditional | 11/06/1998SE |
Questions and answers
When was Modification to Brennen Biosynthetic Surgical Mesh Matrix cleared by the FDA?
Modification to Brennen Biosynthetic Surgical Mesh Matrix (K030460) received a 510(k) decision of Substantially Equivalent on March 7, 2003, 23 days after the submission was received.
What is the product code of K030460?
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.