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Endosi Suction Irrigator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K923201

by Armm Inc.

Identifiers

510(k) Number
K923201 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Endosi Suction Irrigator by Armm Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Armm Inc.
FDA Applicant
Armm, Inc.

Sources (1)

  • FDA 510(k) K923201 24 fields · synced Jun 19, 2026