PuraDerm Gel
FDA 510(k) K143058 · 3-D Matrix, Inc.
510(k) numberK143058
Submission
- Device name
- PuraDerm Gel
- Applicant
- 3-D Matrix, Inc.
Waltham, MA, US - Received
- October 24, 2014
- Decision date
- February 13, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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More from Solventum Germany GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K261504 | PuraStat-RMPHN · Traditional | 08/03/2026SE |
| K261503 | PuraStat GIQAU · Traditional | 08/03/2026SE |
| K222481 | PuraStatQAU · Traditional | 02/28/2023SE |
| K213552 | PuraStat-RMPHN · Traditional | 04/01/2022SE |
| K210211 | PuraStat-OMOLR · Traditional | 10/08/2021SE |
| K210098 | PuraStat-GIQAU · Traditional | 06/25/2021SE |
| K193085 | PuraDERM GelFRO · Traditional | 05/11/2020SE |
| K183015 | PuraSinusNHB · Traditional | 04/12/2019SE |
Questions and answers
When was PuraDerm Gel cleared by the FDA?
PuraDerm Gel (K143058) received a 510(k) decision of Substantially Equivalent on February 13, 2015, 112 days after the submission was received.
What is the product code of K143058?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.