DeviceSignal · 510(k) cleared

Rapid Medical Ltd.

FDA 510(k) decision recorded 2026-08-28 · K260617 · Traditional 510(k)

Event510(k) cleared
Effective2026-08-28
DecisionSESE

On 2026-08-28 the FDA recorded a 510(k) clearance decision for Rapid Medical Ltd., for Tigertriever 13 Ultra Revascularization Device. Clearance K260617. Product code NRY. A clearance is a regulatory decision, not an endorsement of the device.

Reported facts

510(k) number
K260617
Applicant
Rapid Medical Ltd.
Device
Tigertriever 13 Ultra Revascularization Device
Decided on
2026-08-28
Received on
2026-02-25
Decision
SESE
Clearance type
Traditional
Product code
NRY
Review days
184

Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.

Provenance

Source
fda_device_510k
Source record
K260617
Snapshot hash
a17b676375c92ad46cfd0c81b2c18852150764f05c544c0889e193548d652e00
Source URL
https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
Observed
2026-09-08T16:22:09.483Z
Transform
fda_device_510k_to_clearance v1
Event rule
fda_device_510k_cleared v1
Event key
efc63155e9c9287602a45ae43ff73fa3ac67bd8598029c847d7c89675f9d0e91
Signal type
device_clearance.granted

Source terms that apply

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Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)