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FDA 510(k)

Eblator Device

K-Number: K231126 · 2023-08-02

ApplicantE Surgical, LLC
Decision Date2023-08-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Eblator Device is a medical device manufactured by E Surgical, LLC. It received FDA 510(k) clearance on 2023-08-02 under approval number K231126. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eblator Device?

Eblator Device is a medical device that received FDA 510(k) clearance on 2023-08-02. It is manufactured by E Surgical, LLC. The 510(k) number is K231126.

When was Eblator Device approved by the FDA?

Eblator Device received FDA 510(k) clearance on 2023-08-02, under approval number K231126.

What company makes Eblator Device?

Eblator Device is manufactured by E Surgical, LLC.

What is the FDA product code for Eblator Device?

The FDA product code for Eblator Device is GEI.

Other Devices by E Surgical, LLC

K233115Hawkeye Control Unit with Eyas Endoscope

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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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