Temporary, Internal Use Hemostatic
The Temporary, Internal Use Hemostatic (product code POD) is a Class 2 general and plastic surgery device intended to control severely bleeding wounds, regulated under 878.4454. It requires 510(k) clearance and is notably flagged as a life-sustaining/life-supporting device, reflecting its critical role in managing hemorrhage. The device is not classified as an implant.
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Basic Information
- Product Code
- POD
- Device Class
- FDA class 2
- Regulation Number
- 878.4454
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
Intended to control severely bleeding wounds
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243553 | QuikClot Control+ Hemostatic Device | Mar 18, 2025 | Substantially Equivalent | Teleflex Medical |
| K213198 | Ax-Surgi Surgical Hemostat | Jan 05, 2023 | Substantially Equivalent | Advamedica, Inc. |
| K220971 | QuikClot Control+ Hemostatic Dressing | Dec 14, 2022 | Substantially Equivalent | Z-Medica, LLC |
| K200167 | QuikClot Control+ | Apr 23, 2020 | Substantially Equivalent | Z-Medica, LLC |
| K183190 | NuStat | Sep 25, 2019 | Substantially Equivalent | Beeken Biomedical, LLC |
| DEN160012 | D2 Dressing | Jun 30, 2017 | Unknown | Z-Medica, LLC |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.