FDA 510(k)

Encore System

K-Number: K201238 · 2020-10-02

Decision Date2020-10-02

Product CodeORY

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Encore System is the device name listed in this FDA 510(k) record. The listed applicant is Siesta Medical, Inc.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K201238. The device is classified under product code ORY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Encore System?

Encore System is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Siesta Medical, Inc.. The 510(k) number is K201238.

When did Encore System receive FDA 510(k) clearance?

Encore System received FDA 510(k) clearance on 2020-10-02, under 510(k) number K201238.

Who is the listed applicant for Encore System?

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

What is the FDA product code for Encore System?

The FDA product code for Encore System is ORY.

Other records listing Siesta Medical, Inc. as applicant

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.

K213159Encore System K183310Encore System

Related Devices (Code: ORY)

K213159Encore SystemSiesta Medical, Inc.K183310Encore SystemSiesta Medical, Inc.

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.