FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER
K Number: K851112
·
Decision Apr 3, 1985
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
43
Applicant Total
53
Review Days
15
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Basic Information
- Device Name
- RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER
- K Number
- K851112
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- The Huxley Instrument Corp.
- Date Received
- March 19, 1985
- Decision Date
- April 3, 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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Other Clearances by The Huxley Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K852721 | BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420 | Sep 6, 1985 | Substantially Equivalent |
| K853016 | STILLE ANGULAR RONGEUR, 8-3/4 SS 410 | Aug 7, 1985 | Substantially Equivalent |
| K852993 | BONE RONGEURS | Aug 7, 1985 | Substantially Equivalent |
| K853015 | SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420 | Jul 29, 1985 | Substantially Equivalent |
| K852716 | TAYLOR PERCUSSION HAMMER SS 410 OR 420 | Jul 26, 1985 | Substantially Equivalent |
| K852729 | AALSTEAD MOSQ. FORCEPS, STRAIGHT, 5+SS 410 OR 420 | Jul 15, 1985 | Substantially Equivalent |
| K852717 | IRIS FORCEPS, DELICATE, 1X2 TEETH, STRAIGHT, 4XSS | Jul 15, 1985 | Substantially Equivalent |
| K852724 | BACKHAUS TOWEL CLAMP, 5-1/2 + SS 410 OR 420 | Jul 15, 1985 | Substantially Equivalent |
| K852718 | ADSON TISSUE FORCEPS, 1X2 TEETH 4-3/4+SS | Jul 15, 1985 | Substantially Equivalent |
| K852719 | MAYO HEGAR NEEDLE HOLDER, G+SS 410 OR 420 | Jul 15, 1985 | Substantially Equivalent |