Cleared Traditional

K213198 - Ax-Surgi Surgical Hemostat (FDA 510(k) Clearance)

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

K213198 · Advamedica, Inc. · General & Plastic Surgery device
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Jan 2023
Decision
463d
Days
Class 2
Risk

K213198 is an FDA 510(k) clearance for the Ax-Surgi Surgical Hemostat. Classified as Temporary, Internal Use Hemostatic (product code POD), Class II - Special Controls.

Submitted by Advamedica, Inc. (Cambridge, US). The FDA issued a Cleared decision on January 5, 2023 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4454 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Advamedica, Inc. devices

Submission Details

510(k) Number K213198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2021
Decision Date January 05, 2023
Days to Decision 463 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
349d slower than avg
Panel avg: 114d · This submission: 463d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POD Temporary, Internal Use Hemostatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4454
Definition Intended To Control Severely Bleeding Wounds
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.