Data / Medical devices / South Africa / Glycar SA Pty., Ltd.
Glycar SA Pty., Ltd.: FDA-registered device maker in IRENE Gauteng, South Africa, 1 510(k) clearance
Glycar SA Pty., Ltd. is registered with the FDA (registration 9680759) in IRENE Gauteng, South Africa. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 31, 1997. 1 recall event names it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9680759
- FEI number
- 3002807088
- Address
- 1 Albert RD., Box 967, IRENE Gauteng, South Africa, 0062
- Owner or operator
- GLYCAR S.A (9011207)
- Roles
- Manufacturer
- First device listed
- August 29, 2008
- Registered through
- 2027
- Brand names listed
- St. Jude Pericardial Patch w/Encap
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 31, 1997 | K963967 | GLYCAR PERICARDIAL PATCH | DXZ | Substantially Equivalent | Glycar, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 9, 2025 | 97877 | Class I | Ongoing | SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE | The impacted lot may not meet the required tensile strength specification. | accessdata.fda.gov |
Compare with other makers
Updated November 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.