Cleared Traditional

K180152 - gel-e Flex

K180152 · Gel-E, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
154d
Days
-
Risk

K180152 is an FDA 510(k) clearance for the gel-e Flex. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Gel-E, Inc. (College Park, US). The FDA issued a Cleared decision on June 22, 2018 after a review of 154 days - an extended review cycle.

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: 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 Gel-E, Inc. devices

FDA 510(k) Submission Details - K180152

510(k) Number K180152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2018
Decision Date June 22, 2018
Days to Decision 154 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
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

QSY Device Classification - Class 0,

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 93
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K180152.
gel-e Flex+
K182811 · Gel-E, Inc. · Aug 2019
QuikClot Radial
K181641 · Z-Medica, LLC · Dec 2018
IHM Technology Bandage
K180893 · Protege Biomedical · Sep 2018
StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing
K172155 · Statguard, LLC · Apr 2018
Axiostat Chitosan Hemostatic Dressing
K172324 · Advamedica, Inc. · Feb 2018
Bondiloxs Topical Hemostatic Granules
K161274 · Medtrade Products , Ltd. · Jan 2017