FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTIVBRAID
K Number: K223822
·
Decision Jun 2, 2023
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
6
Review Days
163
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ACTIVBRAID
- K Number
- K223822
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Embody, Inc.
- Date Received
- December 21, 2022
- Decision Date
- June 2, 2023
- Product Code
- GAT
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAT), ordered by most recent decision date.
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HyperSuture All Green Extension Line
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Meniscus Versaflex
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pre-Sutured Tendon
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ProZip Knotless Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PowerKnot High Strength Sutures
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Embody, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252647 | Tapestry Biointegrative Implant | Sep 19, 2025 | Substantially Equivalent |
| K220867 | Tapestry Biointegrative Implant | May 23, 2022 | Substantially Equivalent |
| K213958 | Bioabsorbable Anchor | Apr 8, 2022 | Substantially Equivalent |
| K212306 | Tapestry Biointegrative Implant | Nov 2, 2021 | Substantially Equivalent |
| K201572 | TAPESTRY Biointegrative Implant | Oct 19, 2020 | Substantially Equivalent |