Tubal Lumen Support
FDA 510(k) K932114 · Cook Ob/Gyn
510(k) numberK932114
Submission
- Device name
- Tubal Lumen Support
- Applicant
- Cook Ob/Gyn
Spencer, IN, US - Received
- May 3, 1993
- Decision date
- September 27, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HFJ – Prosthesis, Fallopian Tube
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.3650
- Specialty
- Obstetrics/Gynecology
- Implant
- Yes
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Questions and answers
When was Tubal Lumen Support cleared by the FDA?
Tubal Lumen Support (K932114) received a 510(k) decision of Substantially Equivalent on September 27, 1994, 512 days after the submission was received.
What is the product code of K932114?
The FDA product code is HFJ – Prosthesis, Fallopian Tube, a Class II (moderate risk) device regulated under 21 CFR 884.3650.