RecallHawk

Summary

H.S Hospital Service S.P.A received 510(k) clearance for TRAP EASY, a KNW device. Cleared on 2024-10-09.

Details

Source

510(k) Clearance

External ID

K242029

Action Date

2024-10-09

Status

Traditional

Category

device

Product Code

KNW

Product Description

TRAP EASY. Product code: KNW.

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. H.S Hospital Service S.P.A has received 2 total clearances in our database.

H.S Hospital Service S.P.A has 2 FDA actions in our database, including 2 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 H.S Hospital Service S.P.A have FDA actions?

H.S Hospital Service S.P.A has 2 FDA actions in our database, including 0 recalls and 2 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "K242029" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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