FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MARTIN MEDICAL PRO-SPEC MEDIUM VAGINAL SPECULUM
K Number: K863274
·
Decision Sep 2, 1986
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
71
Applicant Total
14
Review Days
8
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Basic Information
- Device Name
- MARTIN MEDICAL PRO-SPEC MEDIUM VAGINAL SPECULUM
- K Number
- K863274
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Martin Medical
- Date Received
- August 25, 1986
- Decision Date
- September 2, 1986
- Product Code
- HIB
- 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 |
|---|---|---|---|
| HIB | Speculum, Vaginal, Nonmetal | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Martin Medical
| K Number | Device Name | ||
|---|---|---|---|
| K873723 | PLASTER VACUUM, 230V MODEL NO. 4183-161 | Dec 10, 1987 | Substantially Equivalent |
| K873721 | PLASTER VACUUM, 115V MODEL NO. 4183-160 | Dec 7, 1987 | Substantially Equivalent |
| K873720 | CAST CUTTER, 230V MODEL NO. 4183-107 | Oct 2, 1987 | Substantially Equivalent |
| K873719 | CAST CUTTER, 115V MODEL NO. 4183-106 | Oct 2, 1987 | Substantially Equivalent |
| K873717 | CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135 | Oct 2, 1987 | Substantially Equivalent |
| K873716 | ADULT WALKING HEEL PRODUCT NO. 4183-130 | Oct 2, 1987 | Substantially Equivalent |
| K873722 | PEDESTAL WALKING HEEL PRODUCT NO. 4183-133 | Oct 2, 1987 | Substantially Equivalent |
| K873718 | CHILD WALKING HEEL PRODUCT NO. 4183-132 | Oct 2, 1987 | Substantially Equivalent |
| K863273 | MARTIN MEDICAL PRO-SCOPE ANOSCOPE | Nov 4, 1986 | Substantially Equivalent |
| K863275 | MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM | Sep 2, 1986 | Substantially Equivalent |