DeviceSignal · 510(k) cleared
Zhejiang Geyi Medical Instrument Co., Ltd.
FDA 510(k) decision recorded 2026-09-08 · K254294 · Traditional 510(k)
Event510(k) cleared
Effective2026-09-08
DecisionSESE
On 2026-09-08 the FDA recorded a 510(k) clearance decision for Zhejiang Geyi Medical Instrument Co., Ltd., for Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A…. Clearance K254294. Product code HIH. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K254294
- Applicant
- Zhejiang Geyi Medical Instrument Co., Ltd.
- Device
- Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)
- Decided on
- 2026-09-08
- Received on
- 2025-12-31
- Decision
- SESE
- Clearance type
- Traditional
- Product code
- HIH
- Review days
- 251
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K254294- Snapshot hash
a3a25028eeae44912b95531a87efac5a606d6a01c346404e56e7ec7fd97b2d35- Source URL
- https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- Observed
- 2026-09-23T12:43:31.676Z
- Transform
fda_device_510k_to_clearance v1- Event rule
fda_device_510k_cleared v1- Event key
fde982dd0437860c28ecc92193bd3875803f8c6d06e0ae1b51b4a6bdcdbd7741- 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)