Shelhigh No-React Biocuff
FDA 510(k) K032893 · Shelhigh, Inc.
510(k) numberK032893
Submission
- Device name
- Shelhigh No-React Biocuff
- Applicant
- Shelhigh, Inc.
Union, NJ, US - Received
- September 17, 2003
- Decision date
- December 19, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
More from Davol Inc., Subsidiary of C. R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023940 | Shelhigh BioringKRH · Traditional | 06/04/2003SE |
| K982101 | Shelhigh No-React Dura ShieldGXQ · Traditional | 05/02/2000SE |
| K991567 | Shelhigh No-React Tissue Repair Patch/Uropatch.FTM · Traditional | 07/14/1999SE |
| K982810 | Shelhigh No-React VascupatchDXZ · Traditional | 10/28/1998SE |
| K981756 | Shelhigh No-React PneumopledgetsFTL · Traditional | 08/05/1998SE |
| K974914 | Shelhigh No-React Pericardial PatchesDXZ · Traditional | 06/03/1998SE |
| K964467 | Shelhigh Pericardial PatchDXZ · Traditional | 09/23/1997SE |
Questions and answers
When was Shelhigh No-React Biocuff cleared by the FDA?
Shelhigh No-React Biocuff (K032893) received a 510(k) decision of Substantially Equivalent on December 19, 2003, 93 days after the submission was received.
What is the product code of K032893?
The FDA product code is FTL – Mesh, Surgical, Polymeric, a Class II (moderate risk) device regulated under 21 CFR 878.3300.