Tuohy Epidural Needles
510(k) K961152
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK961152 | Date19 Mar 1997 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- BSP
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5150
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Tuohy Epidural Needles are conduction needles designed for regional anesthesia. According to the FDA classification, they fall under the category of anesthesia conduction needles, intended for the injection of local anesthetics to provide epidural anesthesia. These needles are specifically engineered to facilitate the administration of epidural blocks, ensuring precise delivery of anesthetic agents into the epidural space.
These needles are supplied in sterile, single-use packaging and are classified as Class II medical devices under FDA regulations. They are available in various gauges and lengths, including the 17 G x 4.5" model, with depth markings to guide insertion. The Tuohy Epidural Needles have received FDA 510(k) clearance (K961152) and are latex-free. They are regulated under the FDA’s § 868.5150 standard for anesthesia conduction needles and are intended for use in clinical settings by trained medical professionals.
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Questions
AI-generated answers, 1 Oct 2026
What is the primary use of Tuohy Epidural Needles?
Tuohy Epidural Needles are designed specifically for regional anesthesia procedures. They facilitate the administration of epidural blocks by delivering local anesthetics directly into the epidural space, ensuring precise and controlled anesthetic delivery for pain management during surgical or labor-related interventions.
Are Tuohy Epidural Needles latex-free and how are they packaged?
Yes, Tuohy Epidural Needles are latex-free, which helps reduce the risk of allergic reactions in patients. They are supplied in sterile, single-use packaging to ensure safety and prevent cross-contamination, adhering to medical device sterility standards.
What sizes and models of Tuohy Epidural Needles are available?
Tuohy Epidural Needles are available in various gauges and lengths, including the commonly used 17G x 4.5" model. The needles feature depth markings to assist clinicians in accurate insertion, ensuring proper placement during epidural anesthesia procedures.
How should Tuohy Epidural Needles be stored?
Tuohy Epidural Needles should be stored in a clean, dry environment, protected from direct sunlight and extreme temperatures. Since they are single-use and sterile, it is critical to maintain their packaging integrity until use to preserve sterility and prevent contamination.
Are Tuohy Epidural Needles regulated by the FDA, and what classification do they fall under?
Yes, Tuohy Epidural Needles are regulated by the FDA and fall under Class II medical devices. They have received FDA 510(k) clearance (K961152) and are intended for use in clinical settings by trained medical professionals, adhering to the FDA’s § 868.5150 standard for anesthesia conduction needles.