NLS

Instrument, Biopsy, Reprocessed

Product code

NLS

Device name

Instrument, Biopsy, Reprocessed

Device class

Class 2

21 CFR

21 CFR 876.1075

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).