DeviceClearance

Product code NLW— Gastroenterology, Urology

REPROCESSED ENDOSCOPIC ELECTRODES

Classification name
Electrode, Electrosurgical, Active, Urological, Reprocessed
Device class
Class 2
Regulation
21 CFR 876.4300
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“The "electrode, electrosurgical, active, urological, reprocessed" is intended to be used endoscopically to contact urologic tissue so as to allow cutting, coagulation, electrodesiccation, or cautery dessication by means of electric current. 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) 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)”

— U.S. Food and Drug Administration, device classification record for product code NLW under 21 CFR 876.4300, via openFDA

Market context for product code NLW

FDA has cleared 1 device under product code NLW, all in 2002, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NLW

Recent clearances under product code NLW

Data sourced from openFDA. This site is unofficial and independent of the FDA.