OverStitch NXT Endoscopic Suturing System
Summary
Apollo Endosurgery, Inc. received 510(k) clearance for OverStitch NXT Endoscopic Suturing System, a OCW device. Cleared on 2023-06-29.
Details
Source
510(k) Clearance
External ID
K231553
Action Date
2023-06-29
Status
Special
Category
device
Product Code
OCW
Product Description
OverStitch NXT Endoscopic Suturing System. Product code: OCW.
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. Apollo Endosurgery, Inc. has received 3 total clearances in our database.
Apollo Endosurgery, Inc. has 3 FDA actions in our database, including 3 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 Apollo Endosurgery, Inc. have FDA actions?
Apollo Endosurgery, Inc. has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231553" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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