FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT
K Number: K960148
·
Decision Mar 25, 1996
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
121
Applicant Total
38
Review Days
74
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Basic Information
- Device Name
- CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT
- K Number
- K960148
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cabot Medical Corp.
- Date Received
- January 11, 1996
- Decision Date
- March 25, 1996
- Product Code
- FAD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FAD | Stent, Ureteral | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Cabot Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K951714 | CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER | Jul 11, 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 |