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FDA 510(k)

SurgTech Bipolar Head System

K-Number: K173455 · 2018-06-14

ApplicantSurgtech, Inc.
Decision Date2018-06-14
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SurgTech Bipolar Head System is a medical device manufactured by Surgtech, Inc.. It received FDA 510(k) clearance on 2018-06-14 under approval number K173455. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgTech Bipolar Head System?

SurgTech Bipolar Head System is a medical device that received FDA 510(k) clearance on 2018-06-14. It is manufactured by Surgtech, Inc.. The 510(k) number is K173455.

When was SurgTech Bipolar Head System approved by the FDA?

SurgTech Bipolar Head System received FDA 510(k) clearance on 2018-06-14, under approval number K173455.

What company makes SurgTech Bipolar Head System?

SurgTech Bipolar Head System is manufactured by Surgtech, Inc..

What is the FDA product code for SurgTech Bipolar Head System?

The FDA product code for SurgTech Bipolar Head System is KWY.

Related Clinical Trials

NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED NCT06482762 Low-Intensity Focused Ultrasound of the Amygdala for Bipolar Disorder ACTIVE_NOT_RECRUITING NCT06649357 Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate RECRUITING

Other Devices by Surgtech, Inc.

K152200SurgTech Interbody System K162125MALUC™ Total Hip Arthroplasty System K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation System K161894SurgTech Trauma System K191192SurgTech GENOLL Total Knee System

Related Devices (Code: KWY)

K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation K170072Fitmore® Hip StemZimmer GmbH K180130ELEOS™ Bipolar Acetabular SystemOnkos Surgical, Inc. K16308140-42mm BiPolar Head and 22mm Femoral HeadSignature Orthopaedics Pty, Ltd. K192236Fitmore Hip StemZimmer GmbH K191016COPAL exchange G Hip and Knee SpacersHeraeus Medical GmbH

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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