Gyrus Acmi PK Button Electrode
FDA 510(k) K093181 · Gyrus Acmi, Inc.
510(k) numberK093181
Submission
- Device name
- Gyrus Acmi PK Button Electrode
- Applicant
- Gyrus Acmi, Inc.
Southborough, MA, US - Received
- October 8, 2009
- Decision date
- February 24, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FAS – Electrode, Electrosurgical, Active, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Gyrus Acmi PK Button Electrode cleared by the FDA?
Gyrus Acmi PK Button Electrode (K093181) received a 510(k) decision of Substantially Equivalent on February 24, 2010, 139 days after the submission was received.
What is the product code of K093181?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.