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FDA 510(k)

PIXEL APP

K-Number: K120473 · 2012-04-09

ApplicantGauss Surgical, Inc.,
Decision Date2012-04-09
Product CodeLWH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PIXEL APP is the device name listed in this FDA 510(k) record. The listed applicant is Gauss Surgical, Inc.,. It received FDA 510(k) clearance on 2012-04-09 under 510(k) number K120473. The device is classified under product code LWH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIXEL APP?

PIXEL APP is a medical device that received FDA 510(k) clearance on 2012-04-09. The listed applicant is Gauss Surgical, Inc.,. The 510(k) number is K120473.

When did PIXEL APP receive FDA 510(k) clearance?

PIXEL APP received FDA 510(k) clearance on 2012-04-09, under 510(k) number K120473.

Who is the listed applicant for PIXEL APP?

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

What is the FDA product code for PIXEL APP?

The FDA product code for PIXEL APP is LWH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Gauss 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.

K163507Triton Sponge SystemK160338Triton SystemK121274PIXEL APP

Related Devices (Code: LWH)

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.

K121274PIXEL APPGauss Surgical, Inc.,K100551ORLOCATE SYSTEM MODEL ORL 100Haldor Advanced Technologies, Ltd.K093557SMARTWAND-DTXClearcount Medical SolutionsK073180SMARTSPONGE PLUS SYSTEMClearcount Medical Solutions, Inc.K071355SMARTSPONGE SYSTEMClearcount Medical Solutions, Inc.K062642RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100ARf Surgical Systems, Inc.

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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