Company ยท US
Glycar, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 1997. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
2recalls (2 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 31, 1997 | K963967 | GLYCAR PERICARDIAL PATCH Glycar, Inc. | DXZ |
| Oct 31, 1997 | K963368 | GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE Glycar, Inc. | DXZ |
| Sep 23, 1996 | K963175 | GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING Glycar, Inc. | FTM |
| Feb 14, 1996 | K954665 | GLYCAR STAPLE STRIPS Glycar, Inc. | FTL |
| Dec 14, 1994 | K942911 | GLYCAR TISSUE REPAIR PATCH Glycar, Inc. | FTL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2025 | Glycar SA Pty., Ltd. SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE Open, Classified |
DXZ | K963967 |
| Nov 25, 2025 | Glycar SA Pty., Ltd. SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE Open, Classified |
DXZ | K963967 |