FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
K Number: K143669
·
Decision Nov 23, 2015
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
52
Applicant Total
5
Review Days
334
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Basic Information
- Device Name
- MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
- K Number
- K143669
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6110
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medgyn Products, Inc.
- Date Received
- December 24, 2014
- Decision Date
- November 23, 2015
- Product Code
- MQF
- 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 |
|---|---|---|---|
| MQF | Catheter, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQF), ordered by most recent decision date.
Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
FDA 510(k)
FDA Class 2
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FemaSeed Intratubal Insemination
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FDA Class 2
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Daylily Single Use Sterile Embryo Transfer Catheter
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Medgyn Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122973 | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE | Jun 12, 2013 | 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 |