PuraSinus
FDA 510(k) K183015 · 3-D Matrix, Inc.
510(k) numberK183015
Submission
- Device name
- PuraSinus
- Applicant
- 3-D Matrix, Inc.
Needham, MA, US - Received
- October 31, 2018
- Decision date
- April 12, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NHB – Polymer, Ear, Nose And Throat, Synthetic, Absorbable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.
Other 510(k)s with product code NHB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260620 | SeptAlign (SPLN001)NHB · Traditional | Spirair, Inc. | 07/30/2026SE |
| K251790 | SeptAlignNHB · Traditional | Spirair, Inc. | 01/16/2026SE |
| K233569 | SeptAlignNHB · Traditional | Spirair, Inc. | 03/22/2024SE |
| K223167 | Spirair Nasal Septal StrapNHB · Traditional | Spirair, Inc. | 08/17/2023SE |
| K210411 | PosiSep EAR Fragmentable Ear DressingNHB · Traditional | Hemostasis, LLC | 05/05/2022SE |
| K192661 | LATERA Absorbable Nasal Implant SystemNHB · Special | Entellus Medical, Inc. (Aka Stryker Ent) | 11/10/2019SE |
| K161191 | Latera Absorbable Nasal ImplantNHB · Special | Spirox, Inc. | 06/23/2016SE |
| K152958 | INEX Absorbable Nasal ImplantNHB · Traditional | Spirox, Inc. | 12/04/2015SE |
| K132920 | Spirox Inex DeviceNHB · Traditional | Spirox, Inc. | 06/10/2014SE |
| K122434 | Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic GelNHB · Special | Medtronic Xomed | 10/31/2012SE |
More from Medtronic Xomed
| 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 |
| K143058 | PuraDerm GelFRO · Traditional | 02/13/2015SE |
Questions and answers
When was PuraSinus cleared by the FDA?
PuraSinus (K183015) received a 510(k) decision of Substantially Equivalent on April 12, 2019, 163 days after the submission was received.
What is the product code of K183015?
The FDA product code is NHB – Polymer, Ear, Nose And Throat, Synthetic, Absorbable, a Class II (moderate risk) device regulated under 21 CFR 874.3620.