Introl Bladder Neck Support Prosthesis with Removal Tool
FDA 510(k) K965040 · Johnson & Johnson Medical, Inc.
510(k) numberK965040
Submission
- Device name
- Introl Bladder Neck Support Prosthesis with Removal Tool
- Applicant
- Johnson & Johnson Medical, Inc.
Arlington, TX, US - Received
- December 17, 1996
- Decision date
- March 10, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HHW – Pessary, Vaginal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.3575
- Specialty
- Obstetrics/Gynecology
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| K240798 | Cntrl+ Bladder Support PessaryHHW · Traditional | Cntrl+, Inc. | 12/17/2024SE |
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| K233548 | Uresta®HHW · Traditional | Resilia, Inc. | 04/03/2024SE |
| K231786 | Gynethotics PessaryHHW · Traditional | Cosm Medical | 03/06/2024SE |
| K190277 | ProVate Vaginal SupportHHW · Traditional | Contipi Medical , Ltd. | 07/08/2019SE |
| K183468 | Revive Reusable Bladder SupportHHW · Traditional | Rinovum Subsidiary 2, LLC | 01/25/2019SE |
| K173351 | Panpac Flexi Shelf PessaryHHW · Abbreviated | Panpac Medical Corporation | 10/31/2018SE |
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Questions and answers
When was Introl Bladder Neck Support Prosthesis with Removal Tool cleared by the FDA?
Introl Bladder Neck Support Prosthesis with Removal Tool (K965040) received a 510(k) decision of Substantially Equivalent on March 10, 1997, 83 days after the submission was received.
What is the product code of K965040?
The FDA product code is HHW – Pessary, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3575.