Coaguloop
FDA 510(k) K991314 · American Medical Systems, Inc.
510(k) numberK991314
Submission
- Device name
- Coaguloop
- Applicant
- American Medical Systems, Inc.
Minnetonka, MN, US - Received
- April 16, 1999
- Decision date
- June 29, 1999
- 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 Coaguloop cleared by the FDA?
Coaguloop (K991314) received a 510(k) decision of Substantially Equivalent on June 29, 1999, 74 days after the submission was received.
What is the product code of K991314?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.