Instrument Clamps Electromagnetic
FDA 510(k) K202609 · Stryker Corporation
510(k) numberK202609
Submission
- Device name
- Instrument Clamps Electromagnetic
- Applicant
- Stryker Corporation
Freiburg, DE - Received
- September 9, 2020
- Decision date
- October 9, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGW – Ear, Nose, And Throat Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
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Questions and answers
When was Instrument Clamps Electromagnetic cleared by the FDA?
Instrument Clamps Electromagnetic (K202609) received a 510(k) decision of Substantially Equivalent on October 9, 2020, 30 days after the submission was received.
What is the product code of K202609?
The FDA product code is PGW – Ear, Nose, And Throat Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.