Non Absorbable Surgical Nylon Suture— 510(k) K212603

Name: FDA 510(k) clearance K212603
Creator: U.S. Food and Drug Administration
Published: 2021-12-22

Substantially Equivalent

Shandong Haidike Medical Product Co., Ltd.

FDA 510(k) clearance K212603 for Non Absorbable Surgical Nylon Suture, Substantially Equivalent on 2021-12-22. Applicant: Shandong Haidike Medical Product Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shandong Haidike Medical Product Co., Ltd.
Product code: Code GAR
Device class: Class 2
Regulation: 21 CFR 878.5020
Advisory panel: General, Plastic Surgery
Date received: 2021-08-17
Decision date: 2021-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Heze, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAR

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K261484 — Tissue Approximation System2026-06-03
K220980 — Tissue Approximation System (TAS)2023-07-05
K212888 — Golnit Nylon Monofilament Suture2022-03-31
K192420 — Crownjun Nylon Suture2020-05-29
K161633 — REXLON, REXSIL2017-03-02

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

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K232355 — Non absorbable Surgical Silk Suture2024-01-16

Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.