Bladder Neck Support Prothesis Fitting Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K933654 FDA 510(k)
- FDA Product Code
- HHW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.3575 FDA 510(k)
- Regulation Number
- 884.3575 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bladder Neck Support Prosthesis Fitting Kit is a set of components used to size, assemble, and fit a bladder neck support prosthesis. It is intended for use in obstetrics and gynecology to provide nonsurgical support of the urethro‑vesical junction and assist clinicians in achieving proper placement of the prosthetic device.
The kit is supplied in its original white case with a pull‑out drawer design and is classified as a Class II medical device (product code HHW). It received traditional FDA 510(k) clearance (K933654) on 1995‑05‑04, indicating substantial equivalence to a predicate device. The clearance was reviewed by the Obstetrics/Gynecology advisory committee.
Frequently asked questions
What is the purpose of the Bladder Neck Support Prosthesis Fitting Kit?
The kit provides clinicians with the components needed to size, assemble, and correctly place a bladder neck support prosthesis, offering nonsurgical support of the urethro‑vesical junction in obstetrics and gynecology patients.
How is the kit supplied and what does the packaging include?
It is delivered in its original white case featuring a pull‑out drawer design, which holds all sizing and assembly components required for the prosthesis, ensuring sterility and organization for clinical use.
Is the kit intended for single‑use or can it be reused?
The kit is designed for single‑use application; each set contains sterile components meant to be used once to maintain safety and performance when fitting the prosthesis.
What regulatory classification does the kit have?
The device is classified as a Class II medical device (product code HHW) and received traditional FDA 510(k) clearance (K933654) on May 4 1995, indicating it is substantially equivalent to a predicate device.
Who reviewed the clearance and what specialty does it pertain to?
The clearance was reviewed by the Obstetrics/Gynecology advisory committee, reflecting the kit’s specific use in supporting the urethro‑vesical junction during obstetric and gynecologic procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BLADDER NECK SUPPORT PROTHESIS FITTING KIT (K933654) — FDA 510 (k ..., Bladder Neck Support Prothesis Fitting Kit 510 (k) FDA Premarket ..., PDF K933654 - Bladder Neck Support Prothesis Fitting Kit, Introl Bladder Neck Support Prosthesis Fitting Kit Johnson ... - eBay, The bladder neck support prosthesis: A nonsurgical approach to stress ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K933654 | Class II | Active |
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Manufacturer
- Manufacturer
- Johnson & Johnson Medical, Inc.
Sources (1)
- FDA 510(k) K933654 24 fields · synced Oct 6, 2026