FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL TROCARS
K Number: K933458
·
Decision May 5, 1994
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
11
Review Days
295
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Basic Information
- Device Name
- SURGICAL TROCARS
- K Number
- K933458
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ximed Medical Systems
- Date Received
- July 14, 1993
- Decision Date
- May 5, 1994
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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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 |
| K922714 | UNIVERSAL IRRIGATION & SUCTION TUBING SET | Aug 3, 1993 | 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 |