gel-e Bandage— 510(k) K172010

Substantially Equivalent

Gel-E, Inc. (Formerly Remedium Technologies, Inc.)

FDA 510(k) clearance K172010 for gel-e Bandage, Substantially Equivalent on 2017-12-07. Applicant: Gel-E, Inc. (Formerly Remedium Technologies, Inc.).

Clearance details

Applicant: Gel-E, Inc. (Formerly Remedium Technologies, Inc.)
Product code: Code KGN
Advisory panel: Unknown
Date received: 2017-07-03
Decision date: 2017-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: College Park, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.