FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS.
K Number: K851110
·
Decision Apr 8, 1985
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
21
Applicant Total
53
Review Days
20
Basic Information
- Device Name
- GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS.
- K Number
- K851110
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- THE HUXLEY INSTRUMENT CORP.
- Date Received
- March 19, 1985
- Decision Date
- April 8, 1985
- Product Code
- HFB
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HFB | Forceps, Biopsy, Gynecological | FDA class 1 | Obstetrics/Gynecology |
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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 |
| K852993 | BONE RONGEURS | Aug 7, 1985 | Substantially Equivalent |
| K853016 | STILLE ANGULAR RONGEUR, 8-3/4 SS 410 | 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 |
| K852720 | THUMB DRESSING FORCEPS, 5+SS 410 OR 420 | Jul 15, 1985 | Substantially Equivalent |
| K852712 | MAYO SCISSORS, 6-3/4 CURVED SS 410 OR 420 | Jul 15, 1985 | Substantially Equivalent |
| K852714 | MAYO DISSECTING SCISSORS, STRAIGHT, 5-1/2 + SS | Jul 15, 1985 | Substantially Equivalent |
| K852719 | MAYO HEGAR NEEDLE HOLDER, G+SS 410 OR 420 | Jul 15, 1985 | Substantially Equivalent |
| K852729 | AALSTEAD MOSQ. FORCEPS, STRAIGHT, 5+SS 410 OR 420 | Jul 15, 1985 | Substantially Equivalent |