FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONOPOLAR CAUTERY RETROGADE TIP #TM-1703
K Number: K873655
·
Decision Dec 15, 1987
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
29
Review Days
96
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Basic Information
- Device Name
- MONOPOLAR CAUTERY RETROGADE TIP #TM-1703
- K Number
- K873655
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Arthropedics, Inc.
- Date Received
- September 10, 1987
- Decision Date
- December 15, 1987
- Product Code
- JOS
- 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 |
|---|---|---|---|
| JOS | Electrode, Electrosurgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Arthropedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873619 | ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS) | Jan 14, 1988 | Substantially Equivalent |
| K873653 | MONOPOLAR CAUTERY BLADE TIP #TM-1701 | Dec 15, 1987 | Substantially Equivalent |
| K873654 | MONOPOLAR CAUTERY CONICAL TIP #TM-1702 | Dec 15, 1987 | Substantially Equivalent |
| K873387 | VIDEO ARTHROSCOPE, 1.7MM X 55 MM | Nov 25, 1987 | Substantially Equivalent |
| K873504 | CUP BIOPSY FORCEPS, RIGHT | Nov 2, 1987 | Substantially Equivalent |
| K872533 | THE CART | Nov 2, 1987 | Substantially Equivalent |
| K873501 | SCISSOR, LEFT | Nov 2, 1987 | Substantially Equivalent |
| K873502 | SCISSOR, RIGHT | Nov 2, 1987 | Substantially Equivalent |
| K873512 | SERRATED GRASPING FORCEPS, RIGHT | Nov 2, 1987 | Substantially Equivalent |
| K873710 | MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350 | Nov 2, 1987 | Substantially Equivalent |