Glycar, Inc.
Medical device manufacturer in Irene, Sout.
5510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K963967 | Glycar Pericardial PatchDXZ · Traditional | 10/31/1997SE |
| K963368 | Glycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch Alternative…DXZ · Traditional | 10/31/1997SE |
| K963175 | Glycar Tissue Repair Patch, Bio-Patch, Uro-SlingFTM · Traditional | 09/23/1996SE |
| K954665 | Glycar Staple StripsFTL · Traditional | 02/14/1996SE |
| K942911 | Glycar Tissue Repair PatchFTL · Traditional | 12/14/1994SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0532-2026 Class I | SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH…The impacted lot may not meet the required tensile strength specification. | 10/09/2025Open, Classified |
| Z-0531-2026 Class I | SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH…The impacted lot may not meet the required tensile strength specification. | 10/09/2025Open, Classified |