DeviceClearance

Product code PBQ— Obstetrics/Gynecology

Apyx

Classification name
Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Device class
Class 2
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Total cleared
8
First cleared
Most recent

FDA classification definition

“Attaching suture or stapling ligaments of the pelvic floor.”

— U.S. Food and Drug Administration, device classification record for product code PBQ under 21 CFR 884.4530, via openFDA

Market context for product code PBQ

FDA has cleared 8 devices under product code PBQ between 2004 and 2026, filed by 7 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

Top applicants under product code PBQ

Recent clearances under product code PBQ

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