Endoform Silver Dermal Template
FDA 510(k) K172318 · Aroa Biosurgery
510(k) numberK172318
Submission
- Device name
- Endoform Silver Dermal Template
- Applicant
- Aroa Biosurgery
Mangere, NZ - Received
- August 1, 2017
- Decision date
- November 17, 2017
- 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 |
|---|---|---|
| K260669 | Endoform Dermal TemplateKGN · Traditional | 06/24/2026SE |
| K250598 | Endoform Reconstructive Template - PLGAFTM · Traditional | 06/03/2025SE |
| K231305 | Endoform Dental MembraneNPL · Traditional | 01/23/2024SE |
| K223373 | EnivoBTA · Traditional | 04/07/2023SE |
| K200502 | Myriad ParticlesKGN · Traditional | 03/31/2021SE |
| K200413 | SymphonyKGN · Traditional | 07/29/2020SE |
| K183398 | Endoform RestellaFTM · Traditional | 04/11/2019SE |
| K181935 | Endoform Reconstructive Template - Non AbsorbableFTL · Traditional | 12/04/2018SE |
| K171231 | Endoform Topical MatrixKGN · Traditional | 06/14/2017SE |
Questions and answers
When was Endoform Silver Dermal Template cleared by the FDA?
Endoform Silver Dermal Template (K172318) received a 510(k) decision of Substantially Equivalent on November 17, 2017, 108 days after the submission was received.
What is the product code of K172318?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.