Identifiers
- 510(k) Number
- K862358 FDA 510(k)
- FDA Product Code
- KNE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5100 FDA 510(k)
- Regulation Number
- 884.5100 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Epicath is an Obstetric Anesthesia Set (Product Code KNE), designed as a sterile assembly of components for administering anesthetic agents during obstetric procedures. It includes antiseptic solutions, needles, needle guides, syringes, and associated accessories, intended for use in controlled clinical settings where obstetric anesthesia is required.
Supplied as a single-use device, the Epicath is intended for sterile application in obstetric anesthesia procedures. It adheres to FDA 510(k) clearance (K862358) under 21 CFR 884.5100, classified as a Class II device with special controls. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use.
Frequently asked questions
What types of obstetric procedures is the Epicath designed to support during anesthesia administration?
The Epicath is specifically designed as a sterile assembly for administering anesthetic agents during obstetric procedures, such as epidurals or spinal blocks. It includes components like antiseptic solutions, needles, and syringes tailored for controlled clinical settings where obstetric anesthesia is required. It is not intended for general anesthesia or non-obstetric uses.
Is the Epicath meant for single-use or can it be reused after sterilization?
The Epicath is explicitly labeled as a single-use device. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety. Sterile medical device protocols must be followed to ensure the device remains intact and uncontaminated prior to use.
How should the Epicath be stored to maintain its sterility before use?
The Epicath must be stored according to sterile medical device protocols to preserve its integrity. Since it is a single-use, sterile assembly, it should remain in its original packaging until immediately before use, protected from moisture, contamination, and physical damage. Avoid exposure to extreme temperatures or direct sunlight.
What regulatory pathway was followed for the Epicath’s clearance, and what classification does it hold?
The Epicath received FDA clearance through a 510(k) submission (K862358) under 21 CFR 884.5100, classified as a Class II device with special controls. It was determined to be *substantially equivalent* to a predicate device and reviewed by the Obstetrics/Gynecology (OB) Advisory Committee. This classification reflects its role as a sterile obstetric anesthesia set.
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: EPICATH (K862358) — FDA 510 (k) | Innolitics, K862358 FDA 510 (k) - EPICATH | Hdc Corp., Epicath 510 (k) FDA Premarket Notification K862358 HDC CORP., 510 (k) K862358 — EPICATH — RegDataLab
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K862358 | Class II | Active |
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Manufacturer
- Manufacturer
- Hdc Corp.
Sources (1)
- FDA 510(k) K862358 24 fields · synced Sep 19, 2026