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FDA 510(k)

Hawkeye Control Unit with Eyas Endoscope

K-Number: K233115 · 2024-02-06

Decision Date2024-02-06
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hawkeye Control Unit with Eyas Endoscope is a medical device manufactured by E Surgical, LLC. It received FDA 510(k) clearance on 2024-02-06 under approval number K233115. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hawkeye Control Unit with Eyas Endoscope?

Hawkeye Control Unit with Eyas Endoscope is a medical device that received FDA 510(k) clearance on 2024-02-06. It is manufactured by E Surgical, LLC. The 510(k) number is K233115.

When was Hawkeye Control Unit with Eyas Endoscope approved by the FDA?

Hawkeye Control Unit with Eyas Endoscope received FDA 510(k) clearance on 2024-02-06, under approval number K233115.

What company makes Hawkeye Control Unit with Eyas Endoscope?

Hawkeye Control Unit with Eyas Endoscope is manufactured by E Surgical, LLC.

What is the FDA product code for Hawkeye Control Unit with Eyas Endoscope?

The FDA product code for Hawkeye Control Unit with Eyas Endoscope is HRX.

Other Devices by E Surgical, LLC

Related Devices (Code: HRX)

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.