Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostom…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K192511

Identifiers

510(k) Number: K192511 FDA 510(k)
FDA Product Code: BTO FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 868.5800 FDA 510(k)
Regulation Number: 868.5800 FDA 510(k)
Advisory Committee: Anesthesiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostom… by Venner Medical (singapore) Pte. Ltd. — Class II — FDA_510K — listed in FDA…

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	K192511	Class II	Active

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Manufacturer

Manufacturer: Venner Medical (singapore) Pte. Ltd.
FDA Applicant: Venner Medical (Singapore) Pte, Ltd.

Sources (1)

FDA 510(k) K192511 24 fields · synced Jun 18, 2026