Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
FDA 510(k) K211490 · Stryker Corporation
510(k) numberK211490
Submission
- Device name
- Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
- Applicant
- Stryker Corporation
Kalamazoo, MI, US - Received
- May 13, 2021
- Decision date
- June 9, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4250
- Specialty
- Ear, Nose, Throat
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| K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderERL · Traditional | Laurimed, LLC | 03/09/2017SE |
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Questions and answers
When was Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 cleared by the FDA?
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 (K211490) received a 510(k) decision of Substantially Equivalent on June 9, 2021, 27 days after the submission was received.
What is the product code of K211490?
The FDA product code is ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, a Class II (moderate risk) device regulated under 21 CFR 874.4250.