FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIDWIFERY/OBSTETRICAL FORCEPS
K Number: K890385
·
Decision Mar 1, 1989
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
9
Applicant Total
63
Review Days
37
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Basic Information
- Device Name
- MIDWIFERY/OBSTETRICAL FORCEPS
- K Number
- K890385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4400
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Kinetic Medical Products
- Date Received
- January 23, 1989
- Decision Date
- March 1, 1989
- Product Code
- HDA
- 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 |
|---|---|---|---|
| HDA | Forceps, Obstetrical | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDA), ordered by most recent decision date.
INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX
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DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX
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TEKNO-MEDICAL OBSTETRICAL FORCEPS
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V. MUELLER OBSTETRICAL (OB) FORCEPS
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CMI VACUUM PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ILC FORCEPS PADS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Kinetic Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K890387 | MALLEABLE PLACENTA CURETTE | Feb 27, 1989 | Substantially Equivalent |
| K890380 | CERVICAL BIOPSY FORCEPS | Feb 27, 1989 | Substantially Equivalent |
| K890382 | COMPRESSION FORCEPS | Feb 27, 1989 | Substantially Equivalent |
| K890376 | VAGINAL SPECULUM | Feb 27, 1989 | Substantially Equivalent |
| K890383 | HYSTERECTOMY FORCEPS | Feb 16, 1989 | Substantially Equivalent |
| K890216 | MICROSURGICAL KERATOME | Feb 16, 1989 | Substantially Equivalent |
| K890378 | UTERINE DRESSING FORCEPS | Feb 13, 1989 | Substantially Equivalent |
| K890379 | UTERINE TENTACULUM | Feb 13, 1989 | Substantially Equivalent |
| K890389 | UMBILICAL SCISSORS | Feb 13, 1989 | Substantially Equivalent |
| K890377 | FIXED-SIZE UTERINE DILATOR | Feb 13, 1989 | Substantially Equivalent |