CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture— 510(k) K170166

Substantially Equivalent

Cpt Sutures Co., Ltd.

FDA 510(k) clearance K170166 for CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture, Substantially Equivalent on 2017-09-29. Applicant: Cpt Sutures Co., Ltd..

Clearance details

Applicant: Cpt Sutures Co., Ltd.
Product code: Code GAM
Advisory panel: General, Plastic Surgery
Date received: 2017-01-19
Decision date: 2017-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phu Thuan Ward District 7, VN

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAM

product code GAM

Death: 45
Injury: 5,711
Malfunction: 30,744
Other: 4
Total: 36,504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.