DeviceClearance

Product code NON— Gastroenterology, Urology

MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS

Classification name
Forceps, Biopsy, Non-Electric, Reprocessed
Device class
Class 1
Regulation
21 CFR 876.1075
Advisory panel
Gastroenterology, Urology
Total cleared
3
First cleared
Most recent

FDA classification definition

“same as procode FCL except this product is for the reprocessed device. 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 NON under 21 CFR 876.1075, via openFDA

Market context for product code NON

FDA has cleared 3 devices under product code NON, all in 2005, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code NON

Recent clearances under product code NON

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