Surgical Sutures with or without Needle— 510(k) K221767

Substantially Equivalent

Huaian Seamen Medical Technology Co., Ltd.

FDA 510(k) clearance K221767 for Surgical Sutures with or without Needle, Substantially Equivalent on 2023-07-31. Applicant: Huaian Seamen Medical Technology Co., Ltd..

Clearance details

Applicant: Huaian Seamen Medical Technology Co., Ltd.
Product code: Code GAP
Advisory panel: General, Plastic Surgery
Date received: 2022-06-17
Decision date: 2023-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huaian, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAP

product code GAP

Death: 3
Injury: 491
Malfunction: 2,253
Total: 2,747

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.