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FDA 510(k)

The EPAD 2 System

K-Number: K182542 · 2019-02-22

ApplicantSafeop Surgical, Inc.
Decision Date2019-02-22
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

The EPAD 2 System is a medical device manufactured by Safeop Surgical, Inc.. It received FDA 510(k) clearance on 2019-02-22 under approval 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. It is manufactured by Safeop Surgical, Inc.. The 510(k) number is K182542.

When was The EPAD 2 System approved by the FDA?

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

What company makes The EPAD 2 System?

The EPAD 2 System is manufactured by Safeop Surgical, Inc..

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

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

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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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