FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
K Number: K190715
·
Decision Dec 13, 2019
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
90
Applicant Total
4
Review Days
269
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Basic Information
- Device Name
- EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
- K Number
- K190715
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4250
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Interscope, Inc.
- Date Received
- March 19, 2019
- Decision Date
- December 13, 2019
- Product Code
- ERL
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | FDA class 2 | Ear, Nose, Throat |
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