Cook Hysterocath
FDA 510(k)Class II (US FDA 510(k))
by Cook, Inc.
Identifiers
- 510(k) Number
- K884291 FDA 510(k)
- FDA Product Code
- KNA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.4530 FDA 510(k)
- Regulation Number
- 884.4530 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cook Hysterocath is a Manual, Specialized Obstetric-Gynecologic Instrument, designed for use in gynecological procedures. It is intended for intrauterine applications, including diagnostic and therapeutic interventions within the uterine cavity, such as hysteroscopy or fluid exchange procedures.
Supplied as a single-use device, the Hysterocath is classified under FDA regulation 884.4530 and cleared via a Traditional 510(k) pathway (K884291). It is intended for sterile use in clinical settings and must be handled according to standard aseptic techniques. The device is not MRI-compatible and is available in sizes referenced by the product code KNA.
Frequently asked questions
What types of gynecological procedures is the Cook Hysterocath designed for, and how does it differ from standard hysteroscopes?
The Cook Hysterocath is specifically designed for intrauterine applications, including diagnostic and therapeutic interventions such as hysteroscopy or fluid exchange procedures within the uterine cavity. Unlike standard hysteroscopes, it is a manual, specialized obstetric-gynecologic instrument tailored for these precise uses. Its design focuses on controlled fluid exchange or visualization within the uterus, making it distinct from general-purpose hysteroscopes.
Is the Cook Hysterocath reusable, or is it intended for single-use only? How should it be handled to maintain sterility?
The Cook Hysterocath is explicitly supplied as a single-use device, meaning it is intended for one-time clinical use only. To maintain sterility, it must be handled according to standard aseptic techniques, as it is designed for sterile use in clinical settings. Discarding it after use ensures compliance with infection control protocols.
What sizes or models of the Cook Hysterocath are available, and how are they identified?
The Cook Hysterocath is available in multiple sizes, each referenced by the product code KNA followed by a unique FEI (Final Establishment Identification) number (e.g., 3005747797, 1718873). These FEI numbers correspond to specific models or variations in the product line, allowing clinicians to select the appropriate size for their procedure.
Can the Cook Hysterocath be used in an MRI environment, or are there any safety concerns related to magnetic fields?
The Cook Hysterocath is not MRI-compatible, meaning it should not be used in an MRI environment. This is due to potential risks from magnetic fields, which could affect the device’s integrity or safety during imaging. Always verify compatibility with your facility’s MRI protocols before use.
How was the Cook Hysterocath cleared for market, and what regulatory pathway was followed?
The Cook Hysterocath was cleared via the Traditional 510(k) pathway (with clearance number K884291) under FDA regulation 884.4530, which governs specialized obstetric-gynecologic instruments. It was determined to be substantially equivalent to a predicate device and reviewed by the Obstetrics/Gynecology (OB) Advisory Committee before clearance.
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: COOK HYSTEROCATH(TM) (K884291) — FDA 510(k) | Innolitics, PDF K884291 - Cook Hysterocath(Tm), Cook Hysterocath (Tm) - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K884291 | Class II | Active |
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Manufacturer
- Manufacturer
- Cook, Inc.
Sources (1)
- FDA 510(k) K884291 24 fields · synced Sep 19, 2026