FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ebb Complete Tamponade System
K Number: K150573
·
Decision Mar 25, 2015
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
9
Applicant Total
6
Review Days
19
Basic Information
- Device Name
- ebb Complete Tamponade System
- K Number
- K150573
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CLINICAL INNOVATIONS, LLC
- Date Received
- March 6, 2015
- Decision Date
- March 25, 2015
- Product Code
- OQY
- 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 |
|---|---|---|---|
| OQY | Intrauterine Tamponade Balloon | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OQY), ordered by most recent decision date.
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Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by CLINICAL INNOVATIONS, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K153591 | ebb Complete Tamponade System | Jan 14, 2016 | Substantially Equivalent |
| K140163 | KOALA TOCO | May 29, 2014 | Substantially Equivalent |
| K131781 | CLEARVIEW TOTAL | May 28, 2014 | Substantially Equivalent |
| K110605 | ROM PLUS | Nov 23, 2011 | Substantially Equivalent |
| K061539 | GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE | Sep 20, 2007 | Substantially Equivalent |