FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
K Number: K973734
·
Decision Feb 5, 1998
Classifications
1
FEI Numbers
331
Registration Numbers
331
Same Product Code
83
Applicant Total
8
Review Days
128
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Basic Information
- Device Name
- STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
- K Number
- K973734
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Welcon, Inc.
- Date Received
- September 30, 1997
- Decision Date
- February 5, 1998
- 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
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR 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
Other Clearances by Welcon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003402 | WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION | May 1, 2001 | Substantially Equivalent |
| K971764 | WELCON HUE-VU URINARY DRAINAGE BAG | Jul 29, 1997 | Substantially Equivalent |
| K912869 | WOMEN AND INFANT'S DELIVERY PACK | Dec 4, 1991 | Substantially Equivalent |
| K904158 | ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY | Nov 29, 1990 | Unknown |
| K894397 | WELCON LIGHT HANDLE | Aug 10, 1989 | Substantially Equivalent |
| K830359 | STERILE CATHERIZATION PROCEDURE TRAYS | Mar 17, 1983 | Substantially Equivalent |
| K813027 | STERILE IRRIGATING SYRINGES, KITS,TRAY | Nov 20, 1981 | Substantially Equivalent |