FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTACT-MICRO COLPOHYSTEROSCOPE
K Number: K810569
·
Decision Jul 16, 1981
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
170
Applicant Total
334
Review Days
135
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Basic Information
- Device Name
- CONTACT-MICRO COLPOHYSTEROSCOPE
- K Number
- K810569
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1690
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date Received
- March 3, 1981
- Decision Date
- July 16, 1981
- Product Code
- HIH
- 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 |
|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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|---|---|---|---|
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| K200740 | HD Video Rhino Laryngoscope | Aug 11, 2020 | Substantially Equivalent |
| K191357 | Flexible HD Cysto-Urethroscope System | Sep 18, 2019 | Substantially Equivalent |
| K182723 | Flexible HD Cysto-Urethroscope System | Apr 23, 2019 | Substantially Equivalent |
| K182186 | CMOS Video-Rhino-Laryngoscope System | Mar 22, 2019 | Substantially Equivalent |
| K183264 | Flex-THOR scope | Jan 18, 2019 | Substantially Equivalent |