FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
K Number: K000266
·
Decision Jul 12, 2001
Classifications
1
FEI Numbers
331
Registration Numbers
331
Same Product Code
83
Applicant Total
4
Review Days
531
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
- PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
- K Number
- K000266
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Primary Care Solutions, Inc.
- Date Received
- January 28, 2000
- Decision Date
- July 12, 2001
- Product Code
- JOL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| JOL | Catheter And Tip, Suction | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOL), ordered by most recent decision date.
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
FDA 510(k)
FDA Class 2
·General Hospital
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
FDA 510(k)
FDA Class 2
·General Hospital
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
FDA 510(k)
FDA Class 2
·General Hospital
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Primary Care Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082330 | PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION | Oct 9, 2008 | Substantially Equivalent |
| K030813 | PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND | May 30, 2003 | Substantially Equivalent |
| K000265 | PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION | Jul 12, 2001 | Substantially Equivalent |