FDA 510(k)

The EPAD 2 System

K-Number: K182542 · 2019-02-22

Decision Date2019-02-22

Product CodeGWF

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

The EPAD 2 System is the device name listed in this FDA 510(k) record. The listed applicant is Safeop Surgical, Inc.. It received FDA 510(k) clearance on 2019-02-22 under 510(k) number K182542. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The EPAD 2 System?

The EPAD 2 System is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Safeop Surgical, Inc.. The 510(k) number is K182542.

When did The EPAD 2 System receive FDA 510(k) clearance?

The EPAD 2 System received FDA 510(k) clearance on 2019-02-22, under 510(k) number K182542.

Who is the listed applicant for The EPAD 2 System?

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

What is the FDA product code for The EPAD 2 System?

The FDA product code for The EPAD 2 System is GWF.

Related Devices (Code: GWF)

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.

K253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology Incorporated K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated K242345Delphi StimulatorQuantalx Neuroscience K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.

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.