FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K-SOL(TM)
K Number: K911587
·
Decision Nov 1, 1991
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
42
Applicant Total
47
Review Days
206
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
- K-SOL(TM)
- K Number
- K911587
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Alcon Laboratories
- Date Received
- April 9, 1991
- Decision Date
- November 1, 1991
- Product Code
- KDN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KDN | System, Perfusion, Kidney | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDN), ordered by most recent decision date.
VI°Port Liver Preservation System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BAROguard Donor Lung Preservation System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
X°Port Lung Preservation System; X°Port Lung Preservation Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DCX Disposable Cassette (DCX)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Belzer UW® Cold Storage Solution (BTLBUW-001)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |