Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

gel-e Flex+ gel OTC

K-Number: K192667 · 2019-10-25

ApplicantGel-E, Inc.
Decision Date2019-10-25
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

gel-e Flex+ gel OTC is the device name listed in this FDA 510(k) record. The listed applicant is Gel-E, Inc.. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K192667. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the gel-e Flex+ gel OTC?

gel-e Flex+ gel OTC is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Gel-E, Inc.. The 510(k) number is K192667.

When did gel-e Flex+ gel OTC receive FDA 510(k) clearance?

gel-e Flex+ gel OTC received FDA 510(k) clearance on 2019-10-25, under 510(k) number K192667.

Who is the listed applicant for gel-e Flex+ gel OTC?

The FDA 510(k) record lists Gel-E, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for gel-e Flex+ gel OTC?

The FDA product code for gel-e Flex+ gel OTC is QSY.

Other records listing Gel-E, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182811gel-e Flex+K180152gel-e Flex

Related Devices (Code: QSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cmSpeciality Fibres and Materials LimitedK250319MFUSE (MS001)Machina Medical, Inc.K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.K240713TRAUMAGEL®Cresilon, Inc.K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑