FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOMETRIAL ASPIRATION BIOSPY KIT 182341
K Number: K771149
·
Decision Jul 27, 1977
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
41
Applicant Total
645
Review Days
30
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Basic Information
- Device Name
- ENDOMETRIAL ASPIRATION BIOSPY KIT 182341
- K Number
- K771149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1175
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- C.R. Bard, Inc.
- Date Received
- June 27, 1977
- Decision Date
- July 27, 1977
- Product Code
- HHK
- 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 |
|---|---|---|---|
| HHK | Curette, Suction, Endometrial (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHK), ordered by most recent decision date.
Uterine Aspiration Set
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CrossGlide ETS Plus
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CrossBay Endometrial Tissue Sampler (ETS)
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DISPOSABLE ENDOMETRIAL SUCTION CURETTE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
THE PANPAC SUCTION CURETTE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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