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FDA 510(k)

3D GraftRasp System

K-Number: K200431 · 2020-05-18

ApplicantSurgentec
Decision Date2020-05-18
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

3D GraftRasp System is the device name listed in this FDA 510(k) record. The listed applicant is Surgentec. It received FDA 510(k) clearance on 2020-05-18 under 510(k) number K200431. 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 3D GraftRasp System?

3D GraftRasp System is a medical device that received FDA 510(k) clearance on 2020-05-18. The listed applicant is Surgentec. The 510(k) number is K200431.

When did 3D GraftRasp System receive FDA 510(k) clearance?

3D GraftRasp System received FDA 510(k) clearance on 2020-05-18, under 510(k) number K200431.

Who is the listed applicant for 3D GraftRasp System?

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

What is the FDA product code for 3D GraftRasp System?

The FDA product code for 3D GraftRasp System is FMF.

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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

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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