PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
Summary
Given Imaging Ltd. (Medtronic) received 510(k) clearance for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E, a NEZ device. Cleared on 2021-08-27.
Details
Source
510(k) Clearance
External ID
K211684
Action Date
2021-08-27
Status
Traditional
Category
device
Product Code
NEZ
Product Description
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E. Product code: NEZ.
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. Given Imaging Ltd. (Medtronic) has received 2 total clearances in our database.
Given Imaging Ltd. (Medtronic) has 2 FDA actions in our database, including 2 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 Given Imaging Ltd. (Medtronic) have FDA actions?
Given Imaging Ltd. (Medtronic) has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K211684" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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