Cleared Special

K150573 - ebb Complete Tamponade System (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K150573 · Clinical Innovations, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
19d
Days
Class 2
Risk

K150573 is an FDA 510(k) clearance for the ebb Complete Tamponade System. Classified as Intrauterine Tamponade Balloon (product code OQY), Class II - Special Controls.

Submitted by Clinical Innovations, LLC (Murray, US). The FDA issued a Cleared decision on March 25, 2015 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Clinical Innovations, LLC devices

Submission Details

510(k) Number K150573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2015
Decision Date March 25, 2015
Days to Decision 19 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d faster than avg
Panel avg: 160d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OQY Intrauterine Tamponade Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
Definition Provides Temporary Control Or Reduction Of Postpartum Uterine Bleeding
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.