DeviceClearance

Product code PGZ— General, Plastic Surgery

XSTAT

Classification name
Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
Device class
Class 2
Regulation
21 CFR 878.4452
Advisory panel
General, Plastic Surgery
Total cleared
7
First cleared
Most recent

FDA classification definition

“To control bleeding in junctional, non-compressible wounds until surgical care is acquired.”

— U.S. Food and Drug Administration, device classification record for product code PGZ under 21 CFR 878.4452, via openFDA

Market context for product code PGZ

FDA has cleared 7 devices under product code PGZ between 2014 and 2025, 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.

Clearances per year

Top applicants under product code PGZ

Recent clearances under product code PGZ

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