RecallHawk

Tigertriever 17 Ultra Revascularization Device

Rapid Medical , Ltd.

Summary

Rapid Medical , Ltd. received 510(k) clearance for Tigertriever 17 Ultra Revascularization Device, a NRY device. Cleared on 2025-10-06.

Details

Source

510(k) Clearance

External ID

K251603

Action Date

2025-10-06

Status

Traditional

Category

device

Product Code

NRY

Product Description

Tigertriever 17 Ultra Revascularization Device. Product code: NRY.

Context & Analysis

A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Rapid Medical , Ltd. has received 5 total clearances in our database.

Rapid Medical , Ltd. has 5 FDA actions in our database, including 5 clearances.

Frequently Asked Questions

What does 510(k) clearance mean?

A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.

How often does Rapid Medical , Ltd. have FDA actions?

Rapid Medical , Ltd. has 5 FDA actions in our database, including 0 recalls and 5 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "K251603" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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