FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP
K Number: K843188
·
Decision Sep 20, 1984
Classifications
1
FEI Numbers
331
Registration Numbers
331
Same Product Code
83
Applicant Total
15
Review Days
38
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Basic Information
- Device Name
- WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP
- K Number
- K843188
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Wells Johnson Co.
- Date Received
- August 13, 1984
- Decision Date
- September 20, 1984
- 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
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WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
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STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
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HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
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Other Clearances by Wells Johnson Co.
| K Number | Device Name | ||
|---|---|---|---|
| K991437 | WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 | Aug 30, 1999 | Substantially Equivalent |
| K984448 | BIRCOLL BALLOON DISSECTOR | Jan 28, 1999 | Substantially Equivalent |
| K971580 | UAS ULTRASONIC ASPIRATOR SYSTEM | Dec 9, 1997 | Substantially Equivalent |
| K945876 | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | Dec 4, 1995 | Substantially Equivalent |
| K945500 | WELLS JOHNSON FIXATION SYSTEM | Sep 21, 1995 | Substantially Equivalent |
| K951519 | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | Jun 14, 1995 | Substantially Equivalent |
| K945877 | WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT | Mar 2, 1995 | Substantially Equivalent |
| K945805 | WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE | Dec 13, 1994 | Substantially Equivalent |
| K854068 | EXTERNAL MECHANICAL FASTENER | Nov 22, 1985 | Substantially Equivalent |
| K832520 | SUCTION TIPS | Oct 20, 1983 | Substantially Equivalent |