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NNH — Needle, Conduction, Anesthesia, Reprocessed Class II

FDA Device Classification

FDA product code NNH covers "Needle, Conduction, Anesthesia, Reprocessed", a Class II medical device regulated under 21 CFR 868.5150. Submissions are reviewed by the Anesthesiology panel.

Classification Details

Product Code
NNH
Device Class
Class II
Regulation Number
868.5150
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Definition

A reprocessed needle is a device used to inject local anesthesia into a patient to provide regional anesthesia. This is the same as "BSP." Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

FDA data resources