da Vinci SP Surgical System (SP1098)
Summary
Intuitive Surgical, Inc. received 510(k) clearance for da Vinci SP Surgical System (SP1098), a NAY device. Cleared on 2025-04-24.
Details
Source
510(k) Clearance
External ID
K243714
Action Date
2025-04-24
Status
Traditional
Category
device
Product Code
NAY
Product Description
da Vinci SP Surgical System (SP1098). Product code: NAY.
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. Intuitive Surgical, Inc. has received 51 total clearances in our database.
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 73 recalls and 51 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 Intuitive Surgical, Inc. have FDA actions?
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 73 recalls and 51 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K243714" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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