FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
APEX SUCTION CURETTE
K Number: K871384
·
Decision May 22, 1987
Classifications
1
FEI Numbers
375
Registration Numbers
375
Same Product Code
35
Applicant Total
6
Review Days
45
Basic Information
- Device Name
- APEX SUCTION CURETTE
- K Number
- K871384
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- APEX MEDICAL, INC.
- Date Received
- April 7, 1987
- Decision Date
- May 22, 1987
- Product Code
- GEA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
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Other Clearances by APEX MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K933965 | APEX MEDICAL AIR PUMPS | Mar 17, 1994 | Substantially Equivalent |
| K902102 | COM-TENS: A NEUROSTIMULATOR | May 30, 1991 | Substantially Equivalent |
| K882816 | PULSAR EM | Apr 27, 1989 | Substantially Equivalent |
| K882468 | ELIMINATOR AIR FILTER | Aug 29, 1988 | Substantially Equivalent |
| K871570 | APEX ALPHA VACUUM PUMP | Aug 18, 1987 | Substantially Equivalent |