Aspiration Catheter (2189)
Summary
Hobbs Medical, Inc. received 510(k) clearance for Aspiration Catheter (2189), a OCX device. Cleared on 2024-09-24.
Details
Source
510(k) Clearance
External ID
K241874
Action Date
2024-09-24
Status
Traditional
Category
device
Product Code
OCX
Product Description
Aspiration Catheter (2189). Product code: OCX.
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.
Hobbs Medical, Inc. has 73 FDA actions in our database, including 72 recalls and 1 clearance.
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 Hobbs Medical, Inc. have FDA actions?
Hobbs Medical, Inc. has 73 FDA actions in our database, including 72 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K241874" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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