Bivona FT16GN35NSA068N

by ICU Medical, Inc.

Bivona FT16GN35NSA068N is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K923878 on 29 Dec 1992 and listed in FDA GUDID since 14 Jul 2016 (UDI-DI 15019517063868), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 closed

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number15019517063868 UDI-DI	Date14 Jul 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK923878	Date29 Dec 1992Decided	StatusActive

Official records

AccessGUDID record UDI-DI 15019517063868
FDA 510(k) database 510(k) number K923878

Across registries

2 registries list this device

FDA 510(k) K923878 decided 29 Dec 1992 Active
FDA GUDID UDI-DI 15019517063868 listed 14 Jul 2016 Listed

Recalls

1 recall · FDA

- Terminated Z-0260-2007 FDA Unclassified (pre-2012) initiated 17 Nov 2006
Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.

Timeline

3 dated events

29 Dec 1992 Cleared FDA 510(k) K923878
17 Nov 2006 Recall initiated FDA recalls Z-0260-2007
14 Jul 2016 Listed FDA GUDID 15019517063868

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Bivona
Generic name: Tracheostomy tube, non-reinforced, non-customized, reusable
Model / reference: FT16GN35NSA068N

Primary DI / UDI-DI: 15019517063868
510(k) Number: K923878
FDA product code: JOH
GMDN term: Tracheostomy tube, non-reinforced, non-customized, reusable

Device class: Class II
Regulation number: 868.5800
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization
MRI safety: MR Conditional

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

Sterilise before use
Single use
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (9, all answered No)