FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAGILL CATHETER INTRO. FORCEPS
K Number: K801273
·
Decision Jul 28, 1980
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
43
Applicant Total
18
Review Days
60
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Basic Information
- Device Name
- MAGILL CATHETER INTRO. FORCEPS
- K Number
- K801273
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- J. Sklar Mfg. Co., Inc.
- Date Received
- May 29, 1980
- Decision Date
- July 28, 1980
- 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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Other Clearances by J. Sklar Mfg. Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843693 | JACOBS HIGH VACUUM SUCTION UNIT 05-2570 | Oct 31, 1984 | Substantially Equivalent |
| K842112 | TISCHLER CERVICAL BIOPSY PUNCH FORCEPS | Jul 3, 1984 | Substantially Equivalent |
| K842111 | KOGAN ENDOSPECULUM 9-1/2 | Jun 19, 1984 | Substantially Equivalent |
| K822448 | SCISSORS, VARIOUS | Sep 14, 1982 | Substantially Equivalent |
| K802457 | KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610 | Jan 12, 1981 | Substantially Equivalent |
| K802458 | KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 | Jan 12, 1981 | Substantially Equivalent |
| K800441 | RUDD-CLINIC HEMORRHOIDAL FORCEPS | Apr 8, 1980 | Substantially Equivalent |
| K790577 | HEMORRHOIDAL LIGATOR | Apr 23, 1979 | Substantially Equivalent |
| K772230 | CANNULA, PERFUSION, FALLOPIAN TUBE | Jan 3, 1978 | Substantially Equivalent |
| K772229 | MINICLAMPS, STABILIZ., FALLOPIAN TUBE | Jan 3, 1978 | Substantially Equivalent |