TK Insulin Syringe with/without Saftey Retractable Device— 510(k) K191639

Name: FDA 510(k) clearance K191639
Creator: U.S. Food and Drug Administration
Published: 2020-09-11

Substantially Equivalent

Anhui Tiankang Medical Technology Co., Ltd.

FDA 510(k) clearance K191639 for TK Insulin Syringe with/without Saftey Retractable Device, Substantially Equivalent on 2020-09-11. Applicant: Anhui Tiankang Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Anhui Tiankang Medical Technology Co., Ltd.
Product code: Code MEG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2019-06-19
Decision date: 2020-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianchang, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Anhui Tiankang Medical Technology Co., Ltd.

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K230756 — TK Pre-Filled Normal Saline Flush Syringe2023-08-12
K222385 — Bifurcated Needle2022-12-06
K220204 — Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle2022-07-14

Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.