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NLSClass II

Instrument, Biopsy, Reprocessed

21 CFR 876.1075 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NLS is the FDA product code for Instrument, Biopsy, Reprocessed, a class II device type, regulated under 21 CFR 876.1075. FDA's definition for this code reads: "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)". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NLS
Device name
Instrument, Biopsy, Reprocessed
FDA 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).
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NLS.