Cleared Traditional

K170334 - XSTAT 30, 3-Pack (FDA 510(k) Clearance)

Also includes:
XSTAT 30, 1-Pack XSTAT 12, 3 Pack XSTAT 12, 1 Pack

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

K170334 · Revmedx, Inc. · General & Plastic Surgery device
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May 2017
Decision
88d
Days
Class 2
Risk

K170334 is an FDA 510(k) clearance for the XSTAT 30, 3-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 May 1, 2017 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Revmedx, Inc. devices

Submission Details

510(k) Number K170334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2017
Decision Date May 01, 2017
Days to Decision 88 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
26d faster than avg
Panel avg: 114d · This submission: 88d
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.