FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EndoCore
K Number: K230778
·
Decision Sep 25, 2023
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
32
Applicant Total
2
Review Days
188
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EndoCore
- K Number
- K230778
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Praxis Medical, LLC
- Date Received
- March 21, 2023
- Decision Date
- September 25, 2023
- Product Code
- KTI
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KTI | Bronchoscope Accessory | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTI), ordered by most recent decision date.
ClearTip TBNA Type
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LungFlow Basket Catheter
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LIA-1 Catheter (542-1)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Disposable Grasping Forceps FG-52D/FG-54D
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Praxis Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K200278 | CytoCore | Mar 31, 2020 | Substantially Equivalent |