Acmi Vista CTR Bipolar Loop Electrode
FDA 510(k) K031001 · Acmi Corporation
510(k) numberK031001
Submission
- Device name
- Acmi Vista CTR Bipolar Loop Electrode
- Applicant
- Acmi Corporation
Southborough, MA, US - Received
- March 31, 2003
- Decision date
- May 21, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Acmi Vista CTR Bipolar Loop Electrode cleared by the FDA?
Acmi Vista CTR Bipolar Loop Electrode (K031001) received a 510(k) decision of Substantially Equivalent on May 21, 2003, 51 days after the submission was received.
What is the product code of K031001?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.