Cleared Traditional

K133144 - SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K133144 · Crossbay Medical, Inc. · Obstetrics & Gynecology device
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Mar 2014
Decision
153d
Days
Class 2
Risk

K133144 is an FDA 510(k) clearance for the SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE. Classified as Cannula, Injector, Uterine, Endometrial Biopsy (product code PGK), Class II - Special Controls.

Submitted by Crossbay Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on March 19, 2014 after a review of 153 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K133144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date March 19, 2014
Days to Decision 153 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 160d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGK Cannula, Injector, Uterine, Endometrial Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
Definition To Deliver Saline And/or Contrast Media To Complete Saline Infusion Sonohysterography And/or Hysterosalpingogram Respectively And To Obtain Endometrial Biopsy
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.