8F Modified Sheath System
Summary
Route 92 Medical, Inc. received 510(k) clearance for 8F Modified Sheath System, a QJP device. Cleared on 2024-10-02.
Details
Source
510(k) Clearance
External ID
K240529
Action Date
2024-10-02
Status
Special
Category
device
Product Code
QJP
Product Description
8F Modified Sheath System. Product code: QJP.
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. Route 92 Medical, Inc. has received 7 total clearances in our database.
Route 92 Medical, Inc. has 12 FDA actions in our database, including 5 recalls and 7 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 Route 92 Medical, Inc. have FDA actions?
Route 92 Medical, Inc. has 12 FDA actions in our database, including 5 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K240529" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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