Tuohy NRFit
by Pajunk GmbH Medizintechnologie
510(k) K160297
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number14048223033903 | Date23 Sep 2019 | StatusListed |
| United States | FDA 510(k)SESE 510(k) | NumberK160297 | Date28 Oct 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic Name
- Epidural needle, non-threaded
- Model / Ref / Catalog
- 1166-4K110
- Primary DI / UDI-DI
- 14048223033903
- 510(k) Number
- FDA Product Code
- BSP
- GMDN Term
- Epidural needle, non-threaded
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5150
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
- GUDID distribution status
- Not in Commercial Distribution
Overview
AI-generated summary, 1 Oct 2026
The Tuohy NRFit is a Needle, Conduction, Anesthetic (With or Without Introducer), designed for regional anesthesia procedures. It facilitates the transient delivery of anesthetics to achieve regional analgesia or assist in epidural catheter placement. The device is engineered to enhance precision and safety in administering local anesthetic agents for procedures such as epidural blocks.
This single-use, sterile device is intended for adult anesthesia applications and is classified under FDA product code BSP as a Class II medical device. It is supplied in a sterile, ready-to-use packaging and must be handled in accordance with aseptic techniques. The NRFit connector design incorporates safety features to minimize the risk of misconnections, ensuring proper administration routes. Authorized under FDA 510(k) clearance (K160297), it adheres to regulatory standards for conduction anesthesia devices.
Other devices from Pajunk GmbH Medizintechnologie
Questions
AI-generated answers, 1 Oct 2026
What is the Tuohy NRFit needle designed for?
The Tuohy NRFit needle is specifically designed for regional anesthesia procedures. It facilitates the transient delivery of anesthetics to achieve regional analgesia or assist in epidural catheter placement, enhancing precision and safety during procedures like epidural blocks.
Is the Tuohy NRFit needle single-use or reusable?
The Tuohy NRFit needle is a single-use device. It is supplied in sterile, ready-to-use packaging, which ensures aseptic handling and compliance with medical standards for transient use in anesthesia procedures.
What safety features does the Tuohy NRFit connector include?
The NRFit connector on the Tuohy needle incorporates design features to minimize the risk of misconnections. This ensures that anesthetics are administered through the correct route, reducing potential errors during regional anesthesia procedures.
What sizes or models of the Tuohy NRFit needle are available?
The Tuohy NRFit needle is classified under FDA product code BSP and is intended for adult anesthesia applications. While the exact gauge or length variations are not specified in the provided data, it is designed to meet the needs of regional anesthesia procedures, ensuring compatibility with standard epidural and catheter placement techniques.
How should the Tuohy NRFit needle be stored?
The Tuohy NRFit needle must be stored in its original, sterile packaging until use. Proper storage ensures sterility and maintains the device’s integrity for single-use applications. Always follow aseptic techniques when handling to prevent contamination.
Properties
Other properties (9)
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No