FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
EndoRotor Device
K Number: DEN200016
·
Decision Dec 23, 2020
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
4
Review Days
282
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
- EndoRotor Device
- K Number
- DEN200016
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.4330
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Interscope, Inc.
- Date Received
- March 16, 2020
- Decision Date
- December 23, 2020
- Product Code
- QNE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| QNE | Endoscopic Pancreatic Debridement Device | FDA class 2 | Gastroenterology, Urology |
Other Clearances by Interscope, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand | Dec 13, 2019 | Substantially Equivalent |
| K181127 | EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control | Jan 3, 2019 | Substantially Equivalent |
| K170120 | EndoRotor | Apr 18, 2017 | Substantially Equivalent |