PBN Fallopian Tube Catheter System
FDA 510(k) K000620 · Medical Device Technologies, Inc.
510(k) numberK000620
Submission
- Device name
- PBN Fallopian Tube Catheter System
- Applicant
- Medical Device Technologies, Inc.
Gainesville, FL, US - Received
- February 24, 2000
- Decision date
- October 30, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MDG – System, Intrafallopian Cannula
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was PBN Fallopian Tube Catheter System cleared by the FDA?
PBN Fallopian Tube Catheter System (K000620) received a 510(k) decision of Substantially Equivalent on October 30, 2000, 249 days after the submission was received.
What is the product code of K000620?
The FDA product code is MDG – System, Intrafallopian Cannula, a Class II (moderate risk) device regulated under 21 CFR 884.4530.