FDA applicant
Sinapi Biomedical (Pty), Ltd.
FDA records 1 decision for Sinapi Biomedical (Pty), Ltd. (Stellenbosch, ZA) in 2023: 1 510(k) clearance. All are in product code OQY (Intrauterine Tamponade Balloon). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sinapi Biomedical (Pty), Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Sinapi Biomedical (Pty), Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report