Local Plexus Block Anesthesia Catheter Kits
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K904440 FDA 510(k)
- FDA Product Code
- CAZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5140 FDA 510(k)
- Regulation Number
- 868.5140 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Local Plexus Block Anesthesia Catheter Kits are classified as an Anesthesia Conduction Kit, designed for regional anesthesia procedures. These kits facilitate the administration of local anesthetics to specific nerve plexuses, enabling prolonged sensory and motor blockade for surgical or diagnostic interventions.
Supplied as single-use sterile kits, these devices are intended for use in clinical settings by trained anesthesiologists. They comply with FDA 510(k) clearance under K-number K904440 and fall under regulation number 868.5140, categorized under product code CAZ. The kits are not MRI-safe and must be stored according to manufacturer instructions to maintain sterility and functionality.
Frequently asked questions
What types of procedures are these catheter kits designed to support with regional anesthesia?
These Local Plexus Block Anesthesia Catheter Kits are specifically designed for regional anesthesia procedures, enabling prolonged sensory and motor blockade for surgical or diagnostic interventions. They are intended for use by trained anesthesiologists to administer local anesthetics to targeted nerve plexuses, facilitating extended pain control during procedures such as orthopedic surgery, limb surgery, or other interventions requiring regional anesthesia.
Are these kits single-use or reusable, and how should they be stored to maintain sterility?
The Local Plexus Block Anesthesia Catheter Kits are supplied as single-use, sterile devices. To maintain sterility and functionality, they must be stored according to the manufacturer’s instructions, which likely include keeping them in their original packaging, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until use.
Can these kits be used in an MRI environment, and what regulatory pathway was followed for their approval?
No, these kits are not MRI-safe, so they should not be used in an MRI environment. The Local Plexus Block Anesthesia Catheter Kits were cleared through the FDA 510(k) pathway under K-number K904440, with a Traditional clearance type and a Substantially Equivalent determination by the Anesthesiology Advisory Committee (AN). They fall under product code CAZ and regulation number 868.5140.
What special considerations should clinicians keep in mind when handling or using these kits?
Since these kits are single-use and sterile, clinicians must ensure proper handling to avoid contamination. Additionally, they are not MRI-safe, so they should not be used in MRI environments. The kits are designed for use by trained anesthesiologists in clinical settings, and adherence to the manufacturer’s storage and usage instructions is critical to maintain functionality and sterility.
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: LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS (K904440) — FDA 510(k ..., 510(k) K904440 — LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS, Preferred Products Local Plexus Block Anesthesia Catheter…, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K904440 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Preferred Medical Products
Sources (1)
- FDA 510(k) K904440 24 fields · synced Sep 19, 2026