HC-1 and HC-1 Classic Colonic Irrigation System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131852 FDA 510(k)
- FDA Product Code
- KPL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5220 FDA 510(k)
- Regulation Number
- 876.5220 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HC-1 and HC-1 Classic are Colonic Irrigation Systems, designed for the mechanical cleansing of the colon via controlled fluid infusion and evacuation. These devices facilitate diagnostic or preparatory procedures in gastroenterology and urology by delivering sterile irrigation solutions under controlled pressure, ensuring thorough colonic lavage.
Supplied as a reusable system, the HC-1 and HC-1 Classic are intended for use in clinical settings such as hospitals or endoscopic units. They comply with FDA 510(k) clearance and MDR requirements, with multiple registration numbers (e.g., 3043011436, 3043012074) reflecting their classification under device class II (KPL). Sterility and proper maintenance are critical for repeated use, and their design adheres to 21 CFR 876.5220 standards for colonic irrigation devices.
Frequently asked questions
What medical specialties primarily use the HC-1 and HC-1 Classic Colonic Irrigation Systems, and why are they relevant to those fields?
The HC-1 and HC-1 Classic are primarily used in gastroenterology and urology specialties. These systems are designed for mechanical colonic cleansing, which is essential for preparing patients for diagnostic procedures like colonoscopies or surgical interventions in these fields. The controlled irrigation ensures thorough lavage, improving visibility and safety during examinations or treatments.
Are the HC-1 and HC-1 Classic systems single-use or reusable, and what maintenance is required for repeated use?
The HC-1 and HC-1 Classic are reusable systems, intended for use in clinical settings like hospitals or endoscopic units. Since they are designed for repeated use, sterility and proper maintenance are critical to ensure safe and effective performance. The manufacturer emphasizes adherence to 21 CFR 876.5220 standards, which likely include cleaning, disinfection, and inspection protocols to maintain functionality and hygiene.
What regulatory pathways have the HC-1 and HC-1 Classic undergone, and how does this affect their use in clinical settings?
The HC-1 and HC-1 Classic have undergone FDA 510(k) clearance and comply with MDR (Medical Device Regulation) requirements, confirming they meet U.S. and EU regulatory standards for colonic irrigation devices. Their classification under device class II (KPL) ensures they undergo rigorous review by advisory committees (e.g., Gastroenterology/Urology) before approval. This pathway guarantees their safety, performance, and suitability for use in hospitals or endoscopic units.
How are the HC-1 and HC-1 Classic systems supplied, and what should clinicians consider when storing them?
The HC-1 and HC-1 Classic are supplied as complete reusable systems, intended for clinical environments like hospitals or endoscopic units. Since they are reusable, clinicians should store them in a clean, dry, and protected environment to prevent contamination. Proper storage also includes following manufacturer guidelines for maintenance, as sterility and functionality are essential for repeated use. The systems should be kept away from direct sunlight or extreme temperatures to preserve their integrity.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K131852 | Class II | Active |
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Manufacturer
- Manufacturer
- Transcendencias Comerciales SL Transcom
Sources (2)
- FDA 510(k) K131852 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 19, 2026