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PGZ — Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use Class II

FDA Device Classification

Classification Details

Product Code
PGZ
Device Class
Class II
Regulation Number
878.4452
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253290revmedxXSTAT P15November 12, 2025
K210676revmedxXSTAT 30 PouchAugust 27, 2021
K180051revmedxXSTAT 30, 1-PackMay 18, 2018
K170334revmedxXSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackMay 1, 2017
K161020revmedxXSTAT-12, 3-Pack, XSTAT-12, 1-PackJuly 28, 2016
K152624revmedxXSTAT 30, 3-PACK, XSTAT 30, 1-PACKDecember 7, 2015
DEN130016revmedxXSTATApril 3, 2014