FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
DISPOSABLE AMNIOTOME
K Number: K883283
·
Decision Oct 18, 1988
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
5
Review Days
75
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Basic Information
- Device Name
- DISPOSABLE AMNIOTOME
- K Number
- K883283
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5070
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Galenica Enterprises, Inc.
- Date Received
- August 4, 1988
- Decision Date
- October 18, 1988
- Product Code
- HGG
- 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 |
|---|---|---|---|
| HGG | Controller, Abortion Unit, Vacuum | FDA class 2 | Obstetrics/Gynecology |
Other Clearances by Galenica Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923656 | LIGHTING SOURCE SYSTEM | Sep 8, 1994 | Substantially Equivalent |
| K896383 | DISPOSABLE EXTERNAL CLAMPS | Dec 6, 1989 | Substantially Equivalent |
| K861017 | GALENICA'S DISPOSABLE ANOSCOPES | Jun 13, 1986 | Substantially Equivalent |
| K841909 | VAGINAL SPECULUM - DISPOSABLE | Jul 31, 1984 | Substantially Equivalent |