ViziShot 2 FLEX

by Olympus Surgical Technologies America 2 variants

510(k) K193517

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

510(k) K193517↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK193517	Date18 Mar 2020Cleared	StatusActive

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-2484-2025 FDA Class I initiated 6 Aug 2025
Potential for undetected, deformed a-traumatic tips.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K193517
FDA Product Code: KTI

Device Class: Class II
Regulation: 21 CFR Part 874.4680
Advisory Committee: Ear, Nose, Throat
FDA Decision: SESE Substantially Equivalent

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