DeviceClearance

Product code NLR— Gastroenterology, Urology

SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES

Classification name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
Device class
Class 2
Regulation
21 CFR 876.4300
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“This device is intended to be used endoscopically to remove tissue and control bleeding by use of high frequency electrical 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).”

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

Market context for product code NLR

FDA has cleared 1 device under product code NLR, all in 2003, 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 NLR

Recent clearances under product code NLR

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