NaturaJel Oral Wound Care Kit— 510(k) K260120

Name: FDA 510(k) clearance K260120
Creator: U.S. Food and Drug Administration
Published: 2026-08-05

Substantially Equivalent

HCS Innovation, LLC

FDA 510(k) clearance K260120 for NaturaJel Oral Wound Care Kit, Substantially Equivalent on 2026-08-05. Applicant: HCS Innovation, LLC. Device class: Unclassified.

Clearance details

Applicant: HCS Innovation, LLC
Product code: Code OLR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2026-01-15
Decision date: 2026-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Union Grove, AL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLR

view all

K251908 — Emanate Tray2026-07-29
K260126 — Curajel Oral Gel2026-06-15
K253816 — MuCover (proposed name) Oral Wound Dressing2026-05-21
K253758 — Dental Cone; Dental Sponge2025-12-18
K252425 — Silatrix Oral Gel2025-10-23

Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

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.