Identifiers
- 510(k) Number
- K901705 FDA 510(k)
- FDA Product Code
- KKX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4370 FDA 510(k)
- Regulation Number
- 878.4370 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CUSTOMED CYSTO PACK II is a surgical drape designed for use in cystoscopy procedures. It is classified under product code KKX and falls within the medical specialty of General and Plastic Surgery. The device is intended to provide sterile draping during surgical interventions to maintain aseptic conditions.
This single-use device is supplied sterile and is intended for disposal after a single procedure. It is regulated under classification 878.4370 as a surgical drape and is not evaluated for MRI compatibility. The device is stored in a dry environment and was authorized through the FDA 510(k) process with a substantially equivalent determination.
Frequently asked questions
What is the CUSTOMED CYSTO PACK II used for?
It is a surgical drape specifically designed for cystoscopy procedures. Its primary function is to provide sterile draping during surgical interventions to maintain aseptic conditions and prevent contamination.
How is the CUSTOMED CYSTO PACK II supplied?
The device is supplied in a sterile format, ready for immediate use in surgical settings. It is packaged to preserve sterility until the point of use and is intended for single-patient application.
Is the CUSTOMED CYSTO PACK II reusable?
No, it is a single-use device. It is intended for disposal after a single procedure to ensure patient safety and maintain sterility standards. Reuse or reprocessing is not indicated.
How should the CUSTOMED CYSTO PACK II be stored?
It should be stored in a dry environment. Proper storage conditions help maintain the integrity of the sterile barrier and prevent damage prior to use.
What regulatory path did the CUSTOMED CYSTO PACK II follow?
It was authorized through the FDA 510(k) process with a substantially equivalent determination. This means it was cleared based on comparison to an existing legally marketed device with similar intended use and technology.
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: CUSTOMED CYSTO PACK II (K901705) — FDA 510 (k) | Innolitics, CUSTOMED CYSTO PACK II 510 (k) K901705 - FDA.report, PDF K901705 - CUSTOMED CYSTO PACK II - 510kdatabase.net, Sterile Cystoscopy Surgical Pack II - Medline
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K901705 | Class II | Active |
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Manufacturer
- Manufacturer
- Customed, Inc.
Sources (1)
- FDA 510(k) K901705 24 fields · synced Sep 28, 2026