FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
GALENICA'S DISPOSABLE ANOSCOPES
K Number: K861017
·
Decision Jun 13, 1986
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
25
Applicant Total
5
Review Days
87
Basic Information
- Device Name
- GALENICA'S DISPOSABLE ANOSCOPES
- K Number
- K861017
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- GALENICA ENTERPRISES, INC.
- Date Received
- March 18, 1986
- Decision Date
- June 13, 1986
- Product Code
- FER
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FER | Anoscope And Accessories | FDA class 2 | Gastroenterology, Urology |
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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 |
| K883283 | DISPOSABLE AMNIOTOME | Oct 18, 1988 | Substantially Equivalent |
| K841909 | VAGINAL SPECULUM - DISPOSABLE | Jul 31, 1984 | Substantially Equivalent |