Allura Vaginal Stent
FDA 510(k) K202542 · Pmt Corporation
510(k) numberK202542
Submission
- Device name
- Allura Vaginal Stent
- Applicant
- Pmt Corporation
Chanhassen, MN, US - Received
- September 2, 2020
- Decision date
- September 30, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
Device classification
- Product code
- KXP – Stent, Vaginal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.3900
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Allura Vaginal Stent cleared by the FDA?
Allura Vaginal Stent (K202542) received a 510(k) decision of Substantially Equivalent on September 30, 2020, 28 days after the submission was received.
What is the product code of K202542?
The FDA product code is KXP – Stent, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3900.