510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Glycar SA Pty., Ltd.

IRENE Gauteng, ZA

GLYCAR SA PTY., LTD. appears in FDA device records in IRENE Gauteng, ZA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Glycar SA Pty., Ltd. between 1994 and 1997. The busiest year on record is 1996, with 2. The most recent is 1997, with 2.

Clearances by year, as a table
510(k) clearance decisions for Glycar SA Pty., Ltd., by decision year
YearClearances
19941
19962
19972
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K963967GLYCAR PERICARDIAL PATCHDXZSubstantially Equivalent
K963368GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLEDXZSubstantially Equivalent
K963175GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLINGFTMSubstantially Equivalent
K954665GLYCAR STAPLE STRIPSFTLSubstantially Equivalent
K942911GLYCAR TISSUE REPAIR PATCHFTLSubstantially Equivalent

Registered establishments

FDA registered establishments for Glycar SA Pty., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96807593002807088GLYCAR SA PTY., LTD.1 ALBERT RD., BOX 967, IRENE Gauteng 0062 ZA2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0532-2026SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENEThe impacted lot may not meet the required tensile strength specification.Class IOpen, Classified
Z-0531-2026SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENEThe impacted lot may not meet the required tensile strength specification.Class IOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain