RADIACARE ORAL WOUND RINSE— 510(k) K964852

Name: FDA 510(k) clearance K964852
Creator: U.S. Food and Drug Administration
Published: 1997-03-03

Substantially Equivalent

Carrington Laboratories, Inc.

FDA 510(k) clearance K964852 for RADIACARE ORAL WOUND RINSE, Substantially Equivalent on 1997-03-03. Applicant: Carrington Laboratories, Inc.. Device class: Unclassified.

Clearance details

Applicant: Carrington Laboratories, Inc.
Product code: Code OLR
Device class: Unclassified
Advisory panel: Unknown
Date received: 1996-12-03
Decision date: 1997-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLR

view all

K260120 — NaturaJel Oral Wound Care Kit2026-08-05
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

More clearances from Carrington Laboratories, Inc.

view all

K022670 — CARRAKLENZ AND ULTRAKLENZ2002-10-17
K012126 — THE SALICEPT ORAL PATCH2001-10-03
K983182 — ALOE THERAPY ORAL RINSE1998-12-10
K962218 — CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG1996-09-12
K961758 — CARASYN HYDROGEL WOUND PRODUCTS1996-07-11

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.