Vistaseal VSTL35

by Ethicon Inc.

Vistaseal VSTL35 is a Class II device made by Ethicon Inc., listed under FDA premarket submission BK190324 and listed in FDA GUDID since 1 Oct 2019 (UDI-DI 10705031462571), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) BK190324

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	Number10705031462571 UDI-DI	Date1 Oct 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberBK190324	Date—	StatusActive

Official records

AccessGUDID record UDI-DI 10705031462571

Across registries

2 registries list this device

FDA premarket submission BK190324 Active
FDA GUDID UDI-DI 10705031462571 listed 1 Oct 2019 Listed

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Vistaseal
Generic name: Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use
Model / Ref / Catalog: VSTL35

Primary DI / UDI-DI: 10705031462571
FDA product code: MZM
GMDN term: Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use

Device class: Class II
Regulation number: 880.5860
GUDID distribution status: In Commercial Distribution

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)