FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELLIK EVACUATOR
K Number: K860266
·
Decision Mar 5, 1986
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
13
Applicant Total
2
Review Days
37
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Basic Information
- Device Name
- ELLIK EVACUATOR
- K Number
- K860266
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4370
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- R. J. Ltd., Ind.
- Date Received
- January 27, 1986
- Decision Date
- March 5, 1986
- Product Code
- KQT
- 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 |
|---|---|---|---|
| KQT | Evacuator, Gastro-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KQT), ordered by most recent decision date.
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Other Clearances by R. J. Ltd., Ind.
| K Number | Device Name | ||
|---|---|---|---|
| K860265 | TELESCOPE PROTECTION TUBE | Apr 7, 1986 | Substantially Equivalent |