FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEEDLES AND SUTURES, SILK & NYLON
K Number: K760158
·
Decision Aug 19, 1976
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
40
Applicant Total
47
Review Days
48
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
- NEEDLES AND SUTURES, SILK & NYLON
- K Number
- K760158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5030
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Alcon Laboratories
- Date Received
- July 2, 1976
- Decision Date
- August 19, 1976
- 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 Alcon Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K062624 | NEXT GENERATION LASER | Nov 5, 2007 | Substantially Equivalent |
| K062865 | SMALL VOLUME SYRINGE | Aug 23, 2007 | Substantially Equivalent |
| K000148 | RGP MULTI-PURPOSE SOLUTION ID 100136 | Apr 11, 2000 | Substantially Equivalent |
| K984573 | OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP | Sep 16, 1999 | Substantially Equivalent |
| K990480 | OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER | May 10, 1999 | Substantially Equivalent |
| K984575 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Jan 14, 1999 | Substantially Equivalent |
| K983973 | OPTI-ONE MULTI-PURPOSE SOLUTION | Dec 18, 1998 | Substantially Equivalent |
| K983780 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Dec 18, 1998 | Substantially Equivalent |
| K981561 | LIQUID ENZYME ID 90133 | Jul 24, 1998 | Substantially Equivalent |
| K981571 | MONARCH IOL DELIVERY SYSTEM | Jul 9, 1998 | Substantially Equivalent |