FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SILK Surgical Suture
K Number: K162396
·
Decision Nov 23, 2016
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
40
Applicant Total
64
Review Days
89
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
- SILK Surgical Suture
- K Number
- K162396
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5030
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teleflexmedical, Inc.
- Date Received
- August 26, 2016
- Decision Date
- November 23, 2016
- Product Code
- GAP
- 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 |
|---|---|---|---|
| GAP | Suture, Nonabsorbable, Silk | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAP), ordered by most recent decision date.
Sofsilk Coated Braided Silk Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Non absorbable Surgical Silk Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Surgical Sutures with or without Needle
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SafePath Suturing System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Teleflexmedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232469 | Rüsch Latex Gold Foley Catheter | Aug 1, 2024 | Substantially Equivalent |
| K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Jul 27, 2023 | Substantially Equivalent |
| K192324 | Sheridan Spiral-Flex Endotracheal Tubes | Dec 6, 2019 | Substantially Equivalent |
| K182847 | Hudson RCI Voldyne Volumetric Exerciser | Jul 1, 2019 | Substantially Equivalent |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | May 24, 2019 | Substantially Equivalent |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter | May 8, 2019 | Unknown |
| K181852 | Percuvance Percutaneous Surgical System | Oct 12, 2018 | Substantially Equivalent |
| K173280 | Neonatal ConchaSmart Breathing Circuits | Aug 2, 2018 | Substantially Equivalent |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | Feb 12, 2018 | Substantially Equivalent |
| K161770 | Rusch Silicone Foley Catheter | May 5, 2017 | Substantially Equivalent |