Versa-Kath Epidural Catheter, Model 156-2124
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K023140 FDA 510(k)
- FDA Product Code
- BSO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5120 FDA 510(k)
- Regulation Number
- 868.5120 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Versa-Kath Epidural Catheter, Model 156-2124, is a catheter, conduction, anesthetic designed for epidural anesthesia procedures. It facilitates the administration of local anesthetics or other therapeutic agents into the epidural space for pain management or surgical anesthesia.
This 21-gauge, steerable catheter is intended for use in anesthesiology settings and is classified as a Class II medical device under FDA regulations. It is supplied as a single-use, non-sterile device and requires sterilization prior to use. The device is regulated under FDA 510(k) clearance (K023140) and adheres to regulation number 868.5120 for epidural catheters.
Frequently asked questions
What is the primary use of the Versa-Kath Epidural Catheter, Model 156-2124, and in which clinical setting is it typically employed?
The Versa-Kath Epidural Catheter, Model 156-2124, is designed for epidural anesthesia procedures, enabling the administration of local anesthetics or therapeutic agents into the epidural space. It is specifically intended for use in anesthesiology settings to manage pain or provide surgical anesthesia.
Is the Versa-Kath Epidural Catheter, Model 156-2124, intended for single-use or can it be reused?
The Versa-Kath Epidural Catheter, Model 156-2124, is supplied as a single-use device and is non-sterile at the time of shipment. It requires sterilization prior to use, which means it is not intended for reuse without reprocessing.
What gauge is the Versa-Kath Epidural Catheter, Model 156-2124, and how does this affect its application?
The Versa-Kath Epidural Catheter, Model 156-2124, is a 21-gauge catheter. This gauge size is commonly used for epidural procedures, balancing flexibility for navigation with sufficient lumen diameter to deliver anesthetics or therapeutic agents effectively.
How is the regulatory pathway for the Versa-Kath Epidural Catheter, Model 156-2124, defined, and what does this mean for its use?
The device follows a traditional 510(k) clearance pathway under the FDA, classified as Substantially Equivalent (SESE) to a predicate device. This means it has been reviewed by the FDA’s Anesthesiology (AN) Advisory Committee and is approved for use in epidural anesthesia procedures as outlined in regulation 868.5120.
What special features does the Versa-Kath Epidural Catheter, Model 156-2124, include that may assist in its placement?
The Versa-Kath Epidural Catheter, Model 156-2124, is described as steerable, which suggests it is designed to allow for greater maneuverability during insertion into the epidural space. This feature can help improve precision and reduce complications during epidural anesthesia 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: VERSA-KATH® - Epimed, Versa-Kath - Epimed, VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 (K023140) — FDA 510 (k ..., VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 - fda.report, Versa-kath Epidural Catheter, Model 156-2124 - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023140 | Class II | Active |
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Manufacturer
- Manufacturer
- Epimed International, Inc.
Sources (1)
- FDA 510(k) K023140 24 fields · synced Sep 19, 2026