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NLS — Instrument, Biopsy, Reprocessed Class II

FDA Device Classification

FDA product code NLS covers "Instrument, Biopsy, Reprocessed", a Class II medical device regulated under 21 CFR 876.1075. Submissions are reviewed by the Gastroenterology, Urology panel.

Classification Details

Product Code
NLS
Device Class
Class II
Regulation Number
876.1075
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

Intended to obtain samples of tissue by cutting and/or other mechanical means. This device is indicated for reuse/reprocessing. 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