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FDA 510(k)

Bifurcated Needle

K-Number: K222385 · 2022-12-06

ApplicantAnhui Tiankang Medical Technology Co., Ltd.
Decision Date2022-12-06
Product CodeSCL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Bifurcated 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 2022-12-06 under 510(k) number K222385. The device is classified under product code SCL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bifurcated Needle?

Bifurcated Needle is a medical device that received FDA 510(k) clearance on 2022-12-06. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K222385.

When did Bifurcated Needle receive FDA 510(k) clearance?

Bifurcated Needle received FDA 510(k) clearance on 2022-12-06, under 510(k) number K222385.

Who is the listed applicant for Bifurcated 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 Bifurcated Needle?

The FDA product code for Bifurcated Needle is SCL.

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

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Related Devices (Code: SCL)

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.

K250983Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)Asistan MedikalK182582Oryum and Ovem Epidermal Deri Prick Test ApplicatorAllergy & Applicator Depot, LLCK172062AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test TrayMedscience Science Research Group, Inc.K162917Allerhope Allergy Skin TesterProcare Industrial Co., Limited

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.

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