FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PuraStat-GI
K Number: K210098
·
Decision Jun 25, 2021
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
10
Applicant Total
7
Review Days
162
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Basic Information
- Device Name
- PuraStat-GI
- K Number
- K210098
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4456
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3-D Matrix, Inc.
- Date Received
- January 14, 2021
- Decision Date
- June 25, 2021
- Product Code
- QAU
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| QAU | Hemostatic Device For Endoscopic Gastrointestinal Use | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QAU), ordered by most recent decision date.
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FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| K193085 | PuraDERM Gel | May 11, 2020 | Substantially Equivalent |
| K183015 | PuraSinus | Apr 12, 2019 | Substantially Equivalent |
| K143058 | PuraDerm Gel | Feb 13, 2015 | Substantially Equivalent |