FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
PuraStat-RM
K Number: K213552
·
Decision Apr 1, 2022
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
3
Applicant Total
7
Review Days
144
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Basic Information
- Device Name
- PuraStat-RM
- K Number
- K213552
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3-D Matrix, Inc.
- Date Received
- November 8, 2021
- Decision Date
- April 1, 2022
- Product Code
- PHN
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| PHN | Protective Coating, Mucoadhesive Application, For The Rectal Mucosa | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PHN), ordered by most recent decision date.
PuraStat
FDA 510(k)
FDA Unclassified
·Unknown
PuraStat
FDA 510(k)
FDA Unclassified
·Unknown
PROCTIGARD
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by 3-D Matrix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K222481 | PuraStat | Feb 28, 2023 | 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 |
| K183015 | PuraSinus | Apr 12, 2019 | Substantially Equivalent |
| K143058 | PuraDerm Gel | Feb 13, 2015 | Substantially Equivalent |