510(k) K240994
K240994 is an FDA 510(k) premarket notification submitted by Nextbiomedical Co., Ltd. for the device "Nexpowder". The FDA issued a decision of Substantially Equivalent on November 27, 2024. The device falls under product code QAU (Hemostatic Device For Endoscopic Gastrointestinal Use), a Class II device regulated under 21 CFR 878.4456. Nextbiomedical Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 2024
- Date Received
- April 11, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemostatic Device For Endoscopic Gastrointestinal Use
- Device Class
- Class II
- Regulation Number
- 878.4456
- Review Panel
- SU
- Submission Type
Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.