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FDA 510(k)

ARTHROTAP

K-Number: K201816 · 2020-10-16

ApplicantAccuro Technologies, Inc.
Decision Date2020-10-16
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ARTHROTAP is the device name listed in this FDA 510(k) record. The listed applicant is Accuro Technologies, Inc.. It received FDA 510(k) clearance on 2020-10-16 under 510(k) number K201816. 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 ARTHROTAP?

ARTHROTAP is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is Accuro Technologies, Inc.. The 510(k) number is K201816.

When did ARTHROTAP receive FDA 510(k) clearance?

ARTHROTAP received FDA 510(k) clearance on 2020-10-16, under 510(k) number K201816.

Who is the listed applicant for ARTHROTAP?

The FDA 510(k) record lists Accuro Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTHROTAP?

The FDA product code for ARTHROTAP is FMF.

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.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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.

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