BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211085 FDA 510(k)
- FDA Product Code
- BSP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5150 FDA 510(k)
- Regulation Number
- 868.5150 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Perisafe Tuohy Epidural Needle and BD Perisafe Weiss Epidural Needle are conduction needles designed for anesthetic procedures. These devices are classified as Needle, Conduction, Anesthetic (With or Without Introducer) and feature specialized bevels and depth markings to facilitate precise needle placement and catheter insertion during epidural anesthesia.
These needles are intended for single-use in clinical settings and are supplied sterile. They are categorized under FDA regulation number 868.5150 and were granted FDA 510K clearance under the Traditional pathway, with a decision date of July 1, 2022. The devices are available in various gauges and lengths, including 17G and 18G, with corresponding lengths such as 3½ inches, and are intended for use in anesthesiology 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: BD® Tuohy Epidural Needle 17 G x 3 1/2 in. - 405092 | BD, BD® Epidural Tray with BD Perisafe™ Tuohy Needle 18 G x 3 1/2 in ..., BD Perisafe™ Epidural Needles - quincemedical.com, BD (company) - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211085 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K211085 24 fields · synced Sep 20, 2026