FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE EMERGENCY OBSTETRICAL KIT
K Number: K941641
·
Decision Oct 3, 1994
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
57
Applicant Total
9
Review Days
182
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DISPOSABLE EMERGENCY OBSTETRICAL KIT
- K Number
- K941641
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gam Industries, Inc.
- Date Received
- April 4, 1994
- Decision Date
- October 3, 1994
- 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.
PANPAC WORD/BARTHOLIN CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Gam Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941336 | COMBO MASK | Sep 9, 1994 | Substantially Equivalent |
| K942021 | MOUTH TO MOUTH BREATHER | Jun 22, 1994 | Substantially Equivalent |
| K936050 | JAW SPREADER | Mar 24, 1994 | Substantially Equivalent |
| K930401 | ALUMINUM FOIL | May 12, 1993 | Substantially Equivalent |
| K926290 | BURN SHEET | Apr 20, 1993 | Substantially Equivalent |
| K925590 | MULTI-TRAUMA DRESSING | Apr 8, 1993 | Substantially Equivalent |
| K915569 | UMBILICAL CLAMP | Sep 23, 1992 | Substantially Equivalent |
| K915303 | FOIL BABY BUNTING | Feb 20, 1992 | Substantially Equivalent |