FDA product code PGZ: Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
PGZ is the FDA product code for non-absorbable, expandable, hemostatic sponge for temporary internal use. It is a Class II device, regulated under 21 CFR 878.4452 and reviewed by the General and Plastic Surgery panel. FDA has cleared 6 510(k) submissions under PGZ, 1 in the last five years. The average 510(k) review took 105 days (median 98); 44 days on average over the last three years. 1 De Novo request was granted under it.
Definition
To control bleeding in junctional, non-compressible wounds until surgical care is acquired.
Classification
| Field | Value |
|---|---|
| Device name | Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use |
| Device class | Class II |
| Regulation | 21 CFR 878.4452 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for PGZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 88 |
| 2018 | 1 | 130 |
| 2021 | 1 | 175 |
| 2025 | 1 | 44 |
Compare with all 510(k) review times · Search every PGZ clearance
Top PGZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Revmedx, Inc. | 6 | 2025-11-12 |
Most recent PGZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253290 | Revmedx, Inc. | XSTAT P15 | 2025-11-12 | 44 |
| K210676 | Revmedx, Inc. | XSTAT 30 Pouch | 2021-08-27 | 175 |
| K180051 | Revmedx, Inc. | XSTAT 30, 1-Pack | 2018-05-18 | 130 |
| K170334 | Revmedx, Inc. | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack | 2017-05-01 | 88 |
| K161020 | Revmedx, Inc. | XSTAT-12, 3-Pack, XSTAT-12, 1-Pack | 2016-07-28 | 107 |
Recalls for PGZ devices
openFDA lists no recalls for product code PGZ.
Frequently asked questions
What is FDA product code PGZ?
PGZ is the FDA product code for non-absorbable, expandable, hemostatic sponge for temporary internal use. It is a Class II device, regulated under 21 CFR 878.4452 and reviewed by the General and Plastic Surgery panel.
What device class is PGZ?
Class II, regulation 21 CFR 878.4452. Typical premarket route: 510(k).
How long does a 510(k) take for product code PGZ?
Across 6 cleared submissions the average was 105 days from receipt to decision (median 98).
Which companies have the most PGZ clearances?
Revmedx, Inc. (6).
Next steps
- Run an FDA pathway report with predicate devices for product code PGZ
- Run a recall and safety report across every PGZ manufacturer
- Watch product code PGZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times