PODClass II
Temporary, Internal Use Hemostatic
21 CFR 878.4454 / General, Plastic Surgery
POD is the FDA product code for Temporary, Internal Use Hemostatic, a class II device type, regulated under 21 CFR 878.4454. FDA's definition for this code reads: "Intended to control severely bleeding wounds". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- POD
- Device name
- Temporary, Internal Use Hemostatic
- FDA definition
- Intended to control severely bleeding wounds
- Regulation
- 21 CFR 878.4454
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 6
- Ingested recalls
- 1
Clearances, product code POD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code POD| Applicant | Clearances |
|---|---|
| Z-Medica, LLC | 3 |
| Advamedica Inc. | 1 |
| Beeken Biomedical LLC | 1 |
| Teleflex Medical | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
