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FDA 510(k)

TK Sterile Piston Syringe without Needle

K-Number: K191642 · 2020-01-06

Decision Date2020-01-06
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TK Sterile Piston Syringe without Needle 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 2020-01-06 under 510(k) number K191642. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TK Sterile Piston Syringe without Needle?

TK Sterile Piston Syringe without Needle is a medical device that received FDA 510(k) clearance on 2020-01-06. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K191642.

When did TK Sterile Piston Syringe without Needle receive FDA 510(k) clearance?

TK Sterile Piston Syringe without Needle received FDA 510(k) clearance on 2020-01-06, under 510(k) number K191642.

Who is the listed applicant for TK Sterile Piston Syringe without Needle?

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 Sterile Piston Syringe without Needle?

The FDA product code for TK Sterile Piston Syringe without Needle is FMF.

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: FMF)

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

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