LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10
Summary
Ethicon Endo Surgery, LLC received 510(k) clearance for LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320), a FZP device. Cleared on 2023-08-29.
Details
Source
510(k) Clearance
External ID
K232313
Action Date
2023-08-29
Status
Special
Category
device
Product Code
FZP
Product Description
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320). Product code: FZP.
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. Ethicon Endo Surgery, LLC has received 12 total clearances in our database.
Ethicon Endo Surgery, LLC has 16 FDA actions in our database, including 4 recalls and 12 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 Ethicon Endo Surgery, LLC have FDA actions?
Ethicon Endo Surgery, LLC has 16 FDA actions in our database, including 4 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232313" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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