Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
Summary
Surgical Instrument Service and Savings, Inc. received 510(k) clearance for Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG), a OWQ device. Cleared on 2025-06-05.
Details
Source
510(k) Clearance
External ID
K250545
Action Date
2025-06-05
Status
Traditional
Category
device
Product Code
OWQ
Product Description
Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG). Product code: OWQ.
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. Surgical Instrument Service and Savings, Inc. has received 10 total clearances in our database.
Surgical Instrument Service and Savings, Inc. has 10 FDA actions in our database, including 10 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 Surgical Instrument Service and Savings, Inc. have FDA actions?
Surgical Instrument Service and Savings, Inc. has 10 FDA actions in our database, including 0 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K250545" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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