CASRRASYN ORAL WOUND DRESSING— 510(k) K953423

Name: FDA 510(k) clearance K953423
Creator: U.S. Food and Drug Administration
Published: 1995-10-11

Substantially Equivalent

Carrington Laboratories, Inc.

FDA 510(k) clearance K953423 for CASRRASYN ORAL WOUND DRESSING, Substantially Equivalent on 1995-10-11. 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: 1995-06-20
Decision date: 1995-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLR

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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.

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K022670 — CARRAKLENZ AND ULTRAKLENZ2002-10-17
K012126 — THE SALICEPT ORAL PATCH2001-10-03
K983182 — ALOE THERAPY ORAL RINSE1998-12-10
K964852 — RADIACARE ORAL WOUND RINSE1997-03-03
K962218 — CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG1996-09-12

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.