FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UMBILICAL SCISSORS
K Number: K890389
·
Decision Feb 13, 1989
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
0
Applicant Total
63
Review Days
21
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Basic Information
- Device Name
- UMBILICAL SCISSORS
- K Number
- K890389
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4520
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Kinetic Medical Products
- Date Received
- January 23, 1989
- Decision Date
- February 13, 1989
- Product Code
- HDJ
- 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 |
|---|---|---|---|
| HDJ | Scissors, Umbilical | FDA class 1 | Obstetrics/Gynecology |
Other Clearances by Kinetic Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K890385 | MIDWIFERY/OBSTETRICAL FORCEPS | Mar 1, 1989 | Substantially Equivalent |
| 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 |
| K890377 | FIXED-SIZE UTERINE DILATOR | Feb 13, 1989 | Substantially Equivalent |