Non absorbable Surgical Polypropylene Suture— 510(k) K230746

Name: FDA 510(k) clearance K230746
Creator: U.S. Food and Drug Administration
Published: 2023-09-14

Substantially Equivalent

Shandong Haidike Medical Products Co., Ltd.

FDA 510(k) clearance K230746 for Non absorbable Surgical Polypropylene Suture, Substantially Equivalent on 2023-09-14. Applicant: Shandong Haidike Medical Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shandong Haidike Medical Products Co., Ltd.
Product code: Code GAW
Device class: Class 2
Regulation: 21 CFR 878.5010
Advisory panel: General, Plastic Surgery
Date received: 2023-03-17
Decision date: 2023-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Heze, CN

Download summary PDF View on FDA.gov ↗

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K233355 — Cypris eXact Suturing System2024-01-12
K221280 — Vesseal2022-12-09
K211178 — DURAMESH Mesh Suture2022-09-02
K192953 — APTOS Threads Polypropylene Surgical Sutures2020-08-27

More clearances from Shandong Haidike Medical Products Co., Ltd.

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K231183 — Non absorbable Surgical Polyester Suture2023-08-25
K210518 — Surgical Face Mask2021-06-14

Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.