FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PuraSinus
K Number: K183015
·
Decision Apr 12, 2019
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
14
Applicant Total
7
Review Days
163
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Basic Information
- Device Name
- PuraSinus
- K Number
- K183015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3-D Matrix, Inc.
- Date Received
- October 31, 2018
- Decision Date
- April 12, 2019
- Product Code
- NHB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
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Other Clearances by 3-D Matrix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K222481 | PuraStat | Feb 28, 2023 | Substantially Equivalent |
| K213552 | PuraStat-RM | Apr 1, 2022 | Substantially Equivalent |
| K210211 | PuraStat-OM | Oct 8, 2021 | Substantially Equivalent |
| K210098 | PuraStat-GI | Jun 25, 2021 | Substantially Equivalent |
| K193085 | PuraDERM Gel | May 11, 2020 | Substantially Equivalent |
| K143058 | PuraDerm Gel | Feb 13, 2015 | Substantially Equivalent |