Product code FDP— Gastroenterology, Urology

ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE

Classification name
Apparatus, Pneumoperitoneum, Automatic
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

Market context for product code FDP

FDA has cleared 1 device under product code FDP, all in 1991, 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 FDP

Recent clearances under product code FDP

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