NNH · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5150
Classification
FDA Product Code
NNH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.5150
Review panel
AN
Medical specialty
Anesthesiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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).