Cleared Traditional

K210676 - XSTAT 30 Pouch (FDA 510(k) Clearance)

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

K210676 · Revmedx, Inc. · General & Plastic Surgery device
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Aug 2021
Decision
175d
Days
Class 2
Risk

K210676 is an FDA 510(k) clearance for the XSTAT 30 Pouch. 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 August 27, 2021 after a review of 175 days - an extended review 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: 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 K210676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2021
Decision Date August 27, 2021
Days to Decision 175 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 114d · This submission: 175d
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.

Regulatory Peers - PGZ Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use

Devices cleared under the same product code (PGZ) and FDA review panel - the closest regulatory comparables to K210676.
XSTAT P15
K253290 · Revmedx, Inc. · Nov 2025