FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER
K Number: K980061
·
Decision Mar 2, 1998
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
28
Applicant Total
19
Review Days
54
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Basic Information
- Device Name
- EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER
- K Number
- K980061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5250
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rocket Medical Plc
- Date Received
- January 7, 1998
- Decision Date
- March 2, 1998
- Product Code
- MFD
- 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 |
|---|---|---|---|
| MFD | Cannula, Intrauterine Insemination | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MFD), ordered by most recent decision date.
INSEMINATION CATHETER, MODEL 320301
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`THE INSEMINATOR' (PROPOSED)
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MEDWORKS VISUALIZATION INSEMINATION CATHETER
FDA 510(k)
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MEDWORKS INSEMINATION CATHETER
FDA 510(k)
FDA Class 2
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MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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| K123033 | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B | Feb 1, 2013 | Substantially Equivalent |
| K052365 | CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE | Oct 17, 2005 | Substantially Equivalent |
| K042264 | GUIDEWIRES | Nov 24, 2004 | Substantially Equivalent |
| K040189 | ENDOMETRIAL SAMPLING SYRINGE | Oct 4, 2004 | Substantially Equivalent |
| K032015 | EMBRYON ULTRASOUND NEEDLE GUIDE | Aug 8, 2003 | Substantially Equivalent |
| K000205 | EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES | Apr 19, 2000 | Substantially Equivalent |