DeviceClearance

Product code NLM— Gastroenterology, Urology

REPROCESSED ENDOSCOPIC TROCAR

Classification name
Laparoscope, General & Plastic Surgery, Reprocessed
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
23
First cleared
Most recent

FDA classification definition

“The "Endoscope and accessories, reprocessed" is intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. 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 NLM under 21 CFR 876.1500, via openFDA

Market context for product code NLM

FDA has cleared 23 devices under product code NLM between 2001 and 2020, filed by 10 applicant companies. 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.

Clearances per year

last 15 years

Top applicants under product code NLM

Recent clearances under product code NLM

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