FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
StitchKit
K Number: K191317
·
Decision Jul 12, 2019
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
16
Applicant Total
2
Review Days
58
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
- StitchKit
- K Number
- K191317
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5035
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Origami Surgical
- Date Received
- May 15, 2019
- Decision Date
- July 12, 2019
- Product Code
- NBY
- 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 |
|---|---|---|---|
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NBY), ordered by most recent decision date.
TissueStat
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GOLNIT Non-aborbable PTFE Surgical Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Biotex
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DemeTECH PTFE Nonabsorbable Surgical Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PTFE SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
C-PTFETM Surgical Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Origami Surgical
| K Number | Device Name | ||
|---|---|---|---|
| K202950 | StitchKit COMBO | Feb 23, 2021 | Substantially Equivalent |