FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOCOAGULATOR 2001 KLI
K Number: K895402
·
Decision Apr 26, 1990
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
52
Applicant Total
38
Review Days
231
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Basic Information
- Device Name
- ENDOCOAGULATOR 2001 KLI
- K Number
- K895402
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4120
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Cabot Medical Corp.
- Date Received
- September 7, 1989
- Decision Date
- April 26, 1990
- Product Code
- HGI
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HGI | Electrocautery, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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ENDOCERVICAL ELECTRODE # 2
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FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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 |
| 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 |