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FDA 510(k)

Reach and CQ'ENCE Circular Staplers

K-Number: K192566 · 2019-10-17

ApplicantReach Surgical, Inc.
Decision Date2019-10-17
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Reach and CQ'ENCE Circular Staplers is a medical device manufactured by Reach Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-17 under approval number K192566. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reach and CQ'ENCE Circular Staplers?

Reach and CQ'ENCE Circular Staplers is a medical device that received FDA 510(k) clearance on 2019-10-17. It is manufactured by Reach Surgical, Inc.. The 510(k) number is K192566.

When was Reach and CQ'ENCE Circular Staplers approved by the FDA?

Reach and CQ'ENCE Circular Staplers received FDA 510(k) clearance on 2019-10-17, under approval number K192566.

What company makes Reach and CQ'ENCE Circular Staplers?

Reach and CQ'ENCE Circular Staplers is manufactured by Reach Surgical, Inc..

What is the FDA product code for Reach and CQ'ENCE Circular Staplers?

The FDA product code for Reach and CQ'ENCE Circular Staplers is GDW.

Related Clinical Trials

NCT05360069 Linear Stapler Versus Circular Stapler in Esophagojejunostomy RECRUITING

Related Devices (Code: GDW)

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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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