TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
Summary
Smith & Nephew, Inc. received 510(k) clearance for TESSA Spatial Surgery System; INTELLIO Tablet (72205455), a SIQ device. Cleared on 2026-07-06.
Details
Source
510(k) Clearance
External ID
DEN250037
Action Date
2026-07-06
Status
Direct
Category
device
Product Code
SIQ
Product Description
TESSA Spatial Surgery System; INTELLIO Tablet (72205455). Product code: SIQ.
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 452 device clearances issued this month. Smith & Nephew, Inc. has received 46 total clearances in our database.
Smith & Nephew, Inc. has 80 FDA actions in our database, including 34 recalls and 46 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 Smith & Nephew, Inc. have FDA actions?
Smith & Nephew, Inc. has 80 FDA actions in our database, including 34 recalls and 46 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "DEN250037" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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