QHC — Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs Class II

FDA Device Classification

FDA product code QHC covers "Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs", a Class II medical device regulated under 21 CFR 876.1075. Submissions are reviewed by the Gastroenterology, Urology panel.

Classification Details

Product Code
QHC
Device Class
Class II
Regulation Number
876.1075
Submission Type
Review Panel
OB
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

Obtain core soft tissue biopsy samples of internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes.