Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TK Insulin Syringe with/without Saftey Retractable Device

K-Number: K191639 · 2020-09-11

Decision Date2020-09-11
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TK Insulin Syringe with/without Saftey Retractable Device is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K191639. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TK Insulin Syringe with/without Saftey Retractable Device?

TK Insulin Syringe with/without Saftey Retractable Device is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K191639.

When did TK Insulin Syringe with/without Saftey Retractable Device receive FDA 510(k) clearance?

TK Insulin Syringe with/without Saftey Retractable Device received FDA 510(k) clearance on 2020-09-11, under 510(k) number K191639.

Who is the listed applicant for TK Insulin Syringe with/without Saftey Retractable Device?

The FDA 510(k) record lists Anhui Tiankang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TK Insulin Syringe with/without Saftey Retractable Device?

The FDA product code for TK Insulin Syringe with/without Saftey Retractable Device is MEG.

Other records listing Anhui Tiankang Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 12 devices →

Related Devices (Code: MEG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.