Non absorbable Surgical Polyester Suture— 510(k) K231183

Name: FDA 510(k) clearance K231183
Creator: U.S. Food and Drug Administration
Published: 2023-08-25

Substantially Equivalent

Shandong Haidike Medical Products Co., Ltd.

FDA 510(k) clearance K231183 for Non absorbable Surgical Polyester Suture, Substantially Equivalent on 2023-08-25. Applicant: Shandong Haidike Medical Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shandong Haidike Medical Products Co., Ltd.
Product code: Code GAT
Device class: Class 2
Regulation: 21 CFR 878.5000
Advisory panel: General, Plastic Surgery
Date received: 2023-04-26
Decision date: 2023-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Heze, CN

Download summary PDF View on FDA.gov ↗

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K254275 — HyperSuture All Green Extension Line2026-03-23
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More clearances from Shandong Haidike Medical Products Co., Ltd.

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K230746 — Non absorbable Surgical Polypropylene Suture2023-09-14
K210518 — Surgical Face Mask2021-06-14

Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

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.