FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO ELECTRODES
K Number: K971838
·
Decision Nov 5, 1997
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
43
Applicant Total
41
Review Days
170
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Basic Information
- Device Name
- MICRO ELECTRODES
- K Number
- K971838
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CooperSurgical, Inc.
- Date Received
- May 19, 1997
- Decision Date
- November 5, 1997
- 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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| K201086 | Advincula Delineator Uterine Manipulator | May 21, 2020 | Substantially Equivalent |
| K200038 | Endosee System | Feb 5, 2020 | Substantially Equivalent |
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| K191291 | Wallace Dual Lumen Oocyte Recovery System | Jun 12, 2019 | Substantially Equivalent |
| K190639 | Endosee System | May 15, 2019 | Substantially Equivalent |
| K182959 | Wallace Dual Lumen Oocyte Recovery System | May 10, 2019 | Substantially Equivalent |
| K183020 | Endosee System | Jan 31, 2019 | Substantially Equivalent |