FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER
K Number: K951714
·
Decision Jul 11, 1995
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
38
Review Days
88
Basic Information
- Device Name
- CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER
- K Number
- K951714
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CABOT MEDICAL CORP.
- Date Received
- April 14, 1995
- Decision Date
- July 11, 1995
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by CABOT MEDICAL CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K960148 | CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT | Mar 25, 1996 | Substantially Equivalent |
| K946109 | CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS | Nov 21, 1995 | Substantially Equivalent |
| K951972 | CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS | Jul 21, 1995 | Substantially Equivalent |
| K941743 | CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP | Apr 19, 1995 | Substantially Equivalent |
| K934115 | 3000 ELECTRONIC INSUFFLATOR MODIFICATION | Mar 15, 1995 | Substantially Equivalent |
| K932293 | CABOT MEDICAL BIPOLAR CUTTING FORCEPS | Jul 27, 1994 | Substantially Equivalent |
| K930954 | THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV | Jun 30, 1994 | Substantially Equivalent |
| K932626 | CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB | Jun 8, 1994 | Substantially Equivalent |
| K935786 | CORSON AND NEZHAT SUCTION/IRRIGATION PROBES | May 19, 1994 | Substantially Equivalent |
| K924631 | CABOT MEDICAL UTERINE RESECTOSCOPE | May 16, 1994 | Substantially Equivalent |