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FDA 510(k)

VITRUVIAN ULTIMATE ASPIRATOR

K-Number: K161722 · 2016-07-26

ApplicantBlack & Black Surgical, Inc.
Decision Date2016-07-26
Product CodeQPB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VITRUVIAN ULTIMATE ASPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Black & Black Surgical, Inc.. It received FDA 510(k) clearance on 2016-07-26 under 510(k) number K161722. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITRUVIAN ULTIMATE ASPIRATOR?

VITRUVIAN ULTIMATE ASPIRATOR is a medical device that received FDA 510(k) clearance on 2016-07-26. The listed applicant is Black & Black Surgical, Inc.. The 510(k) number is K161722.

When did VITRUVIAN ULTIMATE ASPIRATOR receive FDA 510(k) clearance?

VITRUVIAN ULTIMATE ASPIRATOR received FDA 510(k) clearance on 2016-07-26, under 510(k) number K161722.

Who is the listed applicant for VITRUVIAN ULTIMATE ASPIRATOR?

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

What is the FDA product code for VITRUVIAN ULTIMATE ASPIRATOR?

The FDA product code for VITRUVIAN ULTIMATE ASPIRATOR is QPB.

Other records listing Black & Black Surgical, Inc. 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.

K240188Vitruvian LiposaberK170629VITRUVIAN INFILTRATION PUMP

Related Devices (Code: QPB)

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.

K251944Lipocosm Harmonic SystemLipocosm, LLCK253396AYON Body Contouring System™ (AYON SYSTEM)Apyx Medical CorporationK252495LSSA (NP-200)Newpong Co., Ltd.K244050AYON Body Contouring System (AYON SYSTEM)Apyx Medical CorporationK244026PAL 7020 ConsoleMicroaire Surgical Instruments, LLCK242804PAL Aspiration SystemMicroaire Surgical Instruments, LLC

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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