FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
K Number: K211490
·
Decision Jun 9, 2021
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
90
Applicant Total
37
Review Days
27
Basic Information
- Device Name
- Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
- K Number
- K211490
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.4250
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Corporation
- Date Received
- May 13, 2021
- Decision Date
- June 9, 2021
- 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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