FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
K Number: K981464
·
Decision Jul 10, 1998
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
43
Applicant Total
6
Review Days
78
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Basic Information
- Device Name
- OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
- K Number
- K981464
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Omnitech Systems, Inc.
- Date Received
- April 23, 1998
- Decision Date
- July 10, 1998
- Product Code
- KNF
- 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 |
|---|---|---|---|
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Omnitech Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode | Jun 27, 2016 | Substantially Equivalent |
| K050454 | OMNITECH FULGURATING ELECTRODE | May 27, 2005 | Substantially Equivalent |
| K981463 | OMNITECH RESECTOSCOPE ROLLER ELECTRODE | Jul 17, 1998 | Substantially Equivalent |
| K964365 | RESECTOSCOPE CUTTING LOOP ELECTRODE | Apr 22, 1997 | Substantially Equivalent |
| K965093 | OMNITECH RESECTOSCOPE ROLLER ELECTRODE | Mar 19, 1997 | Substantially Equivalent |