Cleared Special

K192667 - gel-e Flex+ gel OTC

K192667 · Gel-E, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
30d
Days
-
Risk

K192667 is an FDA 510(k) clearance for the gel-e Flex+ gel OTC. 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 October 25, 2019 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K192667

510(k) Number K192667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2019
Decision Date October 25, 2019
Days to Decision 30 days
Submission Type Special
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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 126
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K192667.
Hemostatic Xerogel Sponge
K192671 · Solaplus Biotech Co., Ltd. · Aug 2020
OMNI-STAT Vascular (Rapid)
K190012 · Medtrade Product, Ltd. · Dec 2019
NasalCEASE and BleedCEASE
K183622 · Les Laboratoires Brothier S.A. · Dec 2019
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
K192667 · gel-e Flex+ gel OTC
Download PDF FDA Summary Gel-E, Inc.