FDA applicant
Cpt Sutures Co., Ltd.
FDA records 1 decision for Cpt Sutures Co., Ltd. (Phu Thuan Ward District 7, VN) in 2017: 1 510(k) clearance. All are in product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). Its devices cite 2 predicates, 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 Cpt Sutures Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Cpt Sutures Co., 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