510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PGZClass II

Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use

21 CFR 878.4452 / General, Plastic Surgery
FDA source (opens on fda.gov)

PGZ is the FDA product code for Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use, a class II device type, regulated under 21 CFR 878.4452. FDA's definition for this code reads: "To control bleeding in junctional, non-compressible wounds until surgical care is acquired". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PGZ
Device name
Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
FDA definition
To control bleeding in junctional, non-compressible wounds until surgical care is acquired.
Regulation
21 CFR 878.4452
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code PGZ

By decision year
7 clearances under product code PGZ with a decision year between 2014 and 2025, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PGZ by decision year
YearClearances
20141
20151
20161
20171
20181
20211
20251

Applicants with the most clearances

Product code PGZ
Applicants holding the most 510(k) clearances under product code PGZ
ApplicantClearances
Revmedx Inc7

Companies listing this code with FDA

Companies whose registered establishments list this code