FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KRONNER REINFORCING STYLETTE
K Number: K932432
·
Decision Apr 12, 1994
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
10
Review Days
327
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Basic Information
- Device Name
- KRONNER REINFORCING STYLETTE
- K Number
- K932432
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Unimar, Inc.
- Date Received
- May 20, 1993
- Decision Date
- April 12, 1994
- Product Code
- LKF
- 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 |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Unimar, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920803 | HSG TRAY | Oct 19, 1992 | Unknown |
| K910317 | UNI-SEM(TM) | May 1, 1991 | Substantially Equivalent |
| K904473 | KRONNER MANIPUJECTOR | Dec 14, 1990 | Substantially Equivalent |
| K895659 | HUI MINI-FLEX | Dec 19, 1989 | Substantially Equivalent |
| K895403 | ASPIRETTE ENDOCERVICAL ASPIRATOR | Nov 29, 1989 | Substantially Equivalent |
| K894264 | KDF-2.3 | Aug 15, 1989 | Substantially Equivalent |
| K890848 | CERVEX-BRUSH | May 11, 1989 | Substantially Equivalent |
| K854415 | ENDOMETRIAL PIPELLE | Mar 13, 1986 | Substantially Equivalent |
| K810291 | STERILE/DISPOSABLE HSG TRAY | Mar 18, 1981 | Substantially Equivalent |