FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
K Number: K050521
·
Decision May 2, 2005
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
52
Applicant Total
3
Review Days
62
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Basic Information
- Device Name
- EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
- K Number
- K050521
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 884.6110
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inntec, Inc.
- Date Received
- March 1, 2005
- Decision Date
- May 2, 2005
- 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 |
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