Zippere - Bioabsorbable/Non-Absorbable Polymer Sling & Surgical Mesh
FDA 510(k) K030631 · Prosurg, Inc.
510(k) numberK030631
Submission
- Device name
- Zippere - Bioabsorbable/Non-Absorbable Polymer Sling & Surgical Mesh
- Applicant
- Prosurg, Inc.
San Jose, CA, US - Received
- February 28, 2003
- Decision date
- May 19, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FTL – Mesh, Surgical, Polymeric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code FTL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253956 | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)FTL · Traditional | Sofradim Production | 05/21/2026SE |
| K253125 | Parietene Flat Sheet MeshFTL · Special | Medtronic - Sofradim Production | 10/24/2025SE |
| K251955 | Onflex MeshFTL · Special | Davol Inc., Subsidiary of C. R. Bard, Inc. | 07/24/2025SE |
| K251557 | Bard® Mesh; Bard® Mesh Pre-ShapedFTL · Special | Davol, Inc. | 06/12/2025SE |
| K250869 | Parietene Macroporous Mesh (PPM5050 )FTL · Special | Sofradim Production | 04/23/2025SE |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-ShapedFTL · Traditional | Davol, Inc. | 04/09/2025SE |
| K243315 | ProGrip Self-Gripping Polypropylene MeshFTL · Traditional | Sofradim Production | 01/17/2025SE |
| K241250 | 3DMax Light MeshFTL · Special | Davol Inc., Subsidiary of C. R. Bard, Inc. | 06/14/2024SE |
| K232373 | Progrip Self-Gripping Polypropylene MeshFTL · Traditional | Sofradim Production | 01/18/2024SE |
| K233402 | Bard 3DMax MeshFTL · Special | Davol Inc., Subsidiary of C. R. Bard, Inc. | 11/01/2023SE |
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| K120766 | Endoscopic Diagnostic & Treatment System (Modification)FAJ · Traditional | 09/11/2012SE |
| K072528 | Adjustable Bone Plates Bioabsorbable, Self Compression Bone Fixation System & AccessoriesJEY · Traditional | 12/28/2007SE |
| K071138 | Cranioclamp Bioabsorbable Cranial Bone Flap Fixation SystemGXR · Traditional | 08/15/2007SE |
| K070737 | Xsorb Bioabsorbable Craniofacial Bone Fixation System & AccessoriesJEY · Traditional | 07/25/2007SE |
| K070846 | Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring SystemFTL · Traditional | 07/02/2007SE |
| K060326 | Lasertx - Diode Laser & Delivery SystemGEX · Traditional | 04/05/2006SE |
| K050488 | Turbt-Rf Electrodes and Electrosurgical DevicesFAS · Traditional | 04/01/2005SE |
Questions and answers
When was Zippere - Bioabsorbable/Non-Absorbable Polymer Sling & Surgical Mesh cleared by the FDA?
Zippere - Bioabsorbable/Non-Absorbable Polymer Sling & Surgical Mesh (K030631) received a 510(k) decision of Substantially Equivalent on May 19, 2003, 80 days after the submission was received.
What is the product code of K030631?
The FDA product code is FTL – Mesh, Surgical, Polymeric, a Class II (moderate risk) device regulated under 21 CFR 878.3300.