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FDA 510(k)

END 200 Endoscopic Tubeset

K-Number: K202922 · 2021-07-08

ApplicantPalliare , Ltd.
Decision Date2021-07-08
Product CodeFCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

END 200 Endoscopic Tubeset is the device name listed in this FDA 510(k) record. The listed applicant is Palliare , Ltd.. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K202922. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the END 200 Endoscopic Tubeset?

END 200 Endoscopic Tubeset is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Palliare , Ltd.. The 510(k) number is K202922.

When did END 200 Endoscopic Tubeset receive FDA 510(k) clearance?

END 200 Endoscopic Tubeset received FDA 510(k) clearance on 2021-07-08, under 510(k) number K202922.

Who is the listed applicant for END 200 Endoscopic Tubeset?

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

What is the FDA product code for END 200 Endoscopic Tubeset?

The FDA product code for END 200 Endoscopic Tubeset is FCX.

Other records listing Palliare , Ltd. 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.

K232902EVA15 insufflatorK230474EVA5 InsufflatorK222901EVA15 insufflatorK202799EVA15K193520EVA 15 Insufflator

Related Devices (Code: FCX)

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.

K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.K240847MedicCO2LON (MedicCO2LON)Ide Vision, Ltd.K230474EVA5 InsufflatorPalliare , Ltd.K201096CO2mbiLEDKarl Storz Endoscopy America, Inc.K190985BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc.K180711FUJIFILM Endoscopic CO2 Regulator GW-100Fujifilm Corporation

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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