Supramid Extra Surgical Mesh
FDA 510(k) K831723 · S. Jackson, Inc.
510(k) numberK831723
Submission
- Device name
- Supramid Extra Surgical Mesh
- Applicant
- S. Jackson, Inc.
Mchenry, IL, US - Received
- May 31, 1983
- Decision date
- August 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K080216 | Supramesh ExtraFTL · Traditional | 09/15/2008SE |
| K973379 | Sterile Suprafoil Smooth Nylon Foil SheetsFTM · Traditional | 09/25/1997SE |
| K931614 | Mopylen SutureGAW · Traditional | 12/17/1993SE |
| K931613 | Supramid SutureGAR · Traditional | 12/17/1993SE |
| K931612 | Nylamid SutureGAR · Traditional | 12/17/1993SE |
| K922630 | MopylenGAW · Traditional | 10/20/1992SE |
| K912429 | N80-838 Supramid Extra SutureGAR · Traditional | 10/02/1991SE |
| K904052 | Supramid Extra SuturesGAR · Traditional | 10/25/1990SE |
| K852011 | Nylamid Mesh Pad Full & HalfFTM · Traditional | 06/11/1985SE |
| K831725 | Foil in 3 Forms-Non-Sterile SheetsFTM · Traditional | 08/16/1983SE |
Questions and answers
When was Supramid Extra Surgical Mesh cleared by the FDA?
Supramid Extra Surgical Mesh (K831723) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 73 days after the submission was received.
What is the product code of K831723?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.