Cleared Traditional

K161020 - XSTAT-12, 3-Pack, XSTAT-12, 1-Pack (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161020 · Revmedx, Inc. · General & Plastic Surgery device
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Jul 2016
Decision
107d
Days
Class 2
Risk

K161020 is an FDA 510(k) clearance for the XSTAT-12, 3-Pack, XSTAT-12, 1-Pack. Classified as Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use (product code PGZ), Class II - Special Controls.

Submitted by Revmedx, Inc. (Wilsonville,, US). The FDA issued a Cleared decision on July 28, 2016 after a review of 107 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4452 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Revmedx, Inc. devices

Submission Details

510(k) Number K161020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2016
Decision Date July 28, 2016
Days to Decision 107 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 114d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGZ Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4452
Definition To Control Bleeding In Junctional, Non-compressible Wounds Until Surgical Care Is Acquired.
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 General & Plastic Surgery devices follow this clearance model.