FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MI-MARK ENDOCERVICAL SAMPLING SET
K Number: K790923
·
Decision Jun 22, 1979
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
57
Applicant Total
12
Review Days
38
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Basic Information
- Device Name
- MI-MARK ENDOCERVICAL SAMPLING SET
- K Number
- K790923
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Simpson/Basye, Inc.
- Date Received
- May 15, 1979
- Decision Date
- June 22, 1979
- Product Code
- KNA
- 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 |
|---|---|---|---|
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNA), ordered by most recent decision date.
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COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
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GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
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COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
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BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
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EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
FDA 510(k)
FDA Class 2
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Other Clearances by Simpson/Basye, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926179 | SEDLACEK HANDLE | Mar 25, 1994 | Substantially Equivalent |
| K891352 | MARLOW ANAL SPECULUM | Jun 23, 1989 | Substantially Equivalent |
| K891351 | NEWPORT LATERAL VAGINAL RETRACTOR | May 11, 1989 | Substantially Equivalent |
| K891347 | REID ENDOCERVICAL SPREADER | Mar 29, 1989 | Substantially Equivalent |
| K891350 | NEWPORT CERVICAL MANIPULATOR | Mar 29, 1989 | Substantially Equivalent |
| K891349 | CAMPION CERVICAL HOOK | Mar 29, 1989 | Substantially Equivalent |
| K891348 | CAMPION LASER FORCEPS | Mar 22, 1989 | Substantially Equivalent |
| K870276 | HEATED INSTRUMENT BATH | May 7, 1987 | Substantially Equivalent |
| K862717 | HAND MIRROR (ENDOSCOPE) | Jul 30, 1986 | Substantially Equivalent |
| K862629 | SURGICAL LASER ACCESSORIES (SLA) CASE | Jul 17, 1986 | Substantially Equivalent |