DeviceSignal · 510(k) cleared
Roen Surgical, Inc.
FDA 510(k) decision recorded 2026-08-07 · K253505 · Traditional 510(k)
Event510(k) cleared
Effective2026-08-07
DecisionSESE
On 2026-08-07 the FDA recorded a 510(k) clearance decision for Roen Surgical, Inc., for Zamenix P. Clearance K253505. Product code FGB. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K253505
- Applicant
- Roen Surgical, Inc.
- Device
- Zamenix P
- Decided on
- 2026-08-07
- Received on
- 2025-10-31
- Decision
- SESE
- Clearance type
- Traditional
- Product code
- FGB
- Review days
- 280
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K253505- 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
4b417f5a40096a06242cae079c128ed816e890620b77c10f6362219bf25e6fa7- 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)