510(k) K170622
K170622 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component". The FDA issued a decision of Substantially Equivalent on March 31, 2017. The device falls under product code OQY (Intrauterine Tamponade Balloon), a Class II device regulated under 21 CFR 884.4530. Cook Incorporated has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2017
- Date Received
- March 1, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intrauterine Tamponade Balloon
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type
provides temporary control or reduction of postpartum uterine bleeding