TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201142

Identifiers

510(k) Number: K201142 FDA 510(k)
FDA Product Code: ONB FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 880.5440 FDA 510(k)
Regulation Number: 880.5440 FDA 510(k)
Advisory Committee: General Hospital FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR… by Simplivia Healthcare Ltd. — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K201142	Class II	Active

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Manufacturer

Manufacturer: Simplivia Healthcare Ltd.
FDA Applicant: Simplivia Healthcare , Ltd.

Sources (1)

FDA 510(k) K201142 24 fields · synced Jun 19, 2026