FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA
K Number: K852014
·
Decision Aug 7, 1985
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
43
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA
- K Number
- K852014
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Effner and Spreine Co.
- Date Received
- May 9, 1985
- Decision Date
- August 7, 1985
- Product Code
- KOA
- 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 |
|---|---|---|---|
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | FDA class 1 | Gastroenterology, Urology |
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