Cleared Traditional

Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) (K213652) - FDA 510(k) Clearance

K213652 · Cresilon, Inc. · General & Plastic Surgery device
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Jun 2023
Decision
586d
Days
-
Risk

K213652 is an FDA 510(k) clearance for the Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG). Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Cresilon, Inc. (Brooklyn, US). The FDA issued a Cleared decision on June 28, 2023 after a review of 586 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. 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 Cresilon, Inc. devices

Submission Details

510(k) Number K213652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2021
Decision Date June 28, 2023
Days to Decision 586 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
471d slower than avg
Panel avg: 115d · This submission: 586d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.

Regulatory Peers - QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

All 28
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K213652.
RESPONDER Polysaccharide Hemostat
K220525 · Starch Medical, Inc. · Dec 2023
Celox Rapid X-Ray Gauze
K230589 · Medtrade Products , Ltd. · Nov 2023
Hemostatic Dressing
K213413 · Jiangsu Newvalue Medical Products Co., Ltd. · Sep 2023
Zeolite Hemostatic Cotton
K223495 · Hangzhou Zeo-Innov Life Technology Co., Ltd. · May 2023
Axiostat Gauze
K222909 · Advamedica, Inc. · Apr 2023
S.E.A.L. Hemostatic Wound Spray
K210751 · Bc3 Technologies, Inc. · Feb 2023