FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL IRRIGATION & SUCTION TUBING SET
K Number: K922714
·
Decision Aug 3, 1993
Classifications
1
FEI Numbers
331
Registration Numbers
331
Same Product Code
83
Applicant Total
11
Review Days
424
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Basic Information
- Device Name
- UNIVERSAL IRRIGATION & SUCTION TUBING SET
- K Number
- K922714
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ximed Medical Systems
- Date Received
- June 5, 1992
- Decision Date
- August 3, 1993
- 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 |
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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 Ximed Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K943014 | BALLOON ELECTROSURGICAL PROBES AND DEVICES | Mar 11, 1996 | Substantially Equivalent |
| K946377 | ELECTROPROBE SINGLE USE ELECTROSURGICAL PROBES | Mar 24, 1995 | Substantially Equivalent |
| K933757 | HAND-HELD IRRIGATION PUMP | Aug 26, 1994 | Substantially Equivalent |
| K933458 | SURGICAL TROCARS | May 5, 1994 | Substantially Equivalent |
| K922523 | BIPOLAR ELECTROSURGICAL PROBES & INSTRUMENTS | Sep 23, 1992 | Substantially Equivalent |
| K903812 | ELECTROPROBE SINGLE-USE SURGICAL PROBE | Sep 20, 1990 | Substantially Equivalent |
| K900463 | LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS | Mar 22, 1990 | Substantially Equivalent |
| K892933 | INFRALASE-LASERGUIDE DELIVERY SYSTEM | Jun 22, 1989 | Substantially Equivalent |
| K890775 | INFRALASE - LASERGUIDE DELIVERY SYSTEM | Apr 21, 1989 | Substantially Equivalent |
| K891126 | MICROLASE CO2 LASER MICROMANIPULATOR | Mar 17, 1989 | Substantially Equivalent |