FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
K Number: K122973
·
Decision Jun 12, 2013
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
55
Applicant Total
5
Review Days
259
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Basic Information
- Device Name
- AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
- K Number
- K122973
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1630
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medgyn Products, Inc.
- Date Received
- September 26, 2012
- Decision Date
- June 12, 2013
- Product Code
- HEX
- 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 |
|---|---|---|---|
| HEX | Colposcope (And Colpomicroscope) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Medgyn Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K143669 | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter | Nov 23, 2015 | Substantially Equivalent |
| K945179 | BOTTLE COLLECTION SET | Jan 26, 1995 | Substantially Equivalent |
| K880196 | LAMINARIA | May 6, 1988 | Substantially Equivalent |
| K880195 | GYNESCOPE | Mar 14, 1988 | Substantially Equivalent |