DeviceSignal · 510(k) cleared
Hh Global Technology, Inc.
FDA 510(k) decision recorded 2026-08-10 · K262427 · Special 510(k)
Event510(k) cleared
Effective2026-08-10
DecisionSESE
On 2026-08-10 the FDA recorded a 510(k) clearance decision for Hh Global Technology, Inc., for Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…. Clearance K262427. Product code FMI. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K262427
- Applicant
- Hh Global Technology, Inc.
- Device
- Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)
- Decided on
- 2026-08-10
- Received on
- 2026-07-16
- Decision
- SESE
- Clearance type
- Special
- Product code
- FMI
- Review days
- 25
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K262427- 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
300a1736884e42e8ef1404363ca6b47a956923ed1769ae48b86bea292f3f6313- 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)