FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C-PTFETM Surgical Suture
K Number: K173922
·
Decision Mar 26, 2018
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
16
Applicant Total
1
Review Days
90
Basic Information
- Device Name
- C-PTFETM Surgical Suture
- K Number
- K173922
- 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
- CP Medical Inc.
- Date Received
- December 26, 2017
- Decision Date
- March 26, 2018
- 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
StitchKit
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