DeviceSignal · 510(k) cleared
Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
FDA 510(k) decision recorded 2026-07-27 · K260835 · Traditional 510(k)
Event510(k) cleared
Effective2026-07-27
DecisionSESE
On 2026-07-27 the FDA recorded a 510(k) clearance decision for Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.), for ARCHIMEDES Biodegradable Stent (Medium). Clearance K260835. Product code FGE. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K260835
- Applicant
- Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
- Device
- ARCHIMEDES Biodegradable Stent (Medium)
- Decided on
- 2026-07-27
- Received on
- 2026-03-13
- Decision
- SESE
- Clearance type
- Traditional
- Product code
- FGE
- Review days
- 136
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K260835- Snapshot hash
a17b676375c92ad46cfd0c81b2c18852150764f05c544c0889e193548d652e00- Source URL
- https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_510k_to_clearance v1- Event rule
fda_device_510k_cleared v1- Event key
561b58be047bd632d617e5b3f0937b1867bd127bda67c26521c28b0ddf18e8f1- Signal type
device_clearance.granted
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)