RecallHawk

Oxus Sieve Beds

Oxus, Inc.

Summary

Oxus, Inc. received 510(k) clearance for Oxus Sieve Beds, a CAW device. Cleared on 2023-05-31.

Details

Source

510(k) Clearance

External ID

K211056

Action Date

2023-05-31

Status

Traditional

Category

device

Product Code

CAW

Product Description

Oxus Sieve Beds. Product code: CAW.

Company

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.

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 Oxus, Inc. have FDA actions?

This is the only FDA action we have on record for Oxus, Inc. in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "K211056" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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