DeviceClearance

Product code POD— General, Plastic Surgery

Ax-Surgi Surgical Hemostat

Classification name
Temporary, Internal Use Hemostatic
Device class
Class 2
Regulation
21 CFR 878.4454
Advisory panel
General, Plastic Surgery
Total cleared
6
First cleared
Most recent

FDA classification definition

“Intended to control severely bleeding wounds”

— U.S. Food and Drug Administration, device classification record for product code POD under 21 CFR 878.4454, via openFDA

Market context for product code POD

FDA has cleared 6 devices under product code POD between 2017 and 2025, filed by 4 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 POD

Recent clearances under product code POD

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