Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Trak Plus Male Fertility Testing System

K-Number: K172514 · 2017-11-17

ApplicantSandstone Diagnostics, Inc.
Decision Date2017-11-17
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Trak Plus Male Fertility Testing System is a medical device manufactured by Sandstone Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-11-17 under approval number K172514. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Trak Plus Male Fertility Testing System?

Trak Plus Male Fertility Testing System is a medical device that received FDA 510(k) clearance on 2017-11-17. It is manufactured by Sandstone Diagnostics, Inc.. The 510(k) number is K172514.

When was Trak Plus Male Fertility Testing System approved by the FDA?

Trak Plus Male Fertility Testing System received FDA 510(k) clearance on 2017-11-17, under approval number K172514.

What company makes Trak Plus Male Fertility Testing System?

Trak Plus Male Fertility Testing System is manufactured by Sandstone Diagnostics, Inc..

What is the FDA product code for Trak Plus Male Fertility Testing System?

The FDA product code for Trak Plus Male Fertility Testing System is POV.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT07608614 Sleep and Performance RECRUITING NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease RECRUITING

Related PubMed Literature

PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

Other Devices by Sandstone Diagnostics, Inc.

K153683Trak Male Fertility Testing System

Related Devices (Code: POV)

K161493YO Home Sperm TestMedical Electronic Systems , Ltd. K153683Trak Male Fertility Testing SystemSandstone Diagnostics, Inc. K180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerBonraybio Co., Ltd. K183602SwimCount Sperm Quality TestMotilitycount Aps K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd. K220828SQA-iO Sperm Quality AnalyzerMedical Electronic Systems , Ltd.

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.

↑