Caphosol® Artifical Saliva (32 doses sachet box)— 510(k) K234015

Name: FDA 510(k) clearance K234015
Creator: U.S. Food and Drug Administration
Published: 2024-03-11

Substantially Equivalent

Eusa Pharma (Uk) Limited

FDA 510(k) clearance K234015 for Caphosol® Artifical Saliva (32 doses sachet box), Substantially Equivalent on 2024-03-11. Applicant: Eusa Pharma (Uk) Limited. Device class: Unclassified.

Clearance details

Applicant: Eusa Pharma (Uk) Limited
Product code: Code LFD
Device class: Unclassified
Advisory panel: Unknown
Date received: 2023-12-19
Decision date: 2024-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hemel Hempstead, GB

Download summary PDF View on FDA.gov ↗

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K162167 — Caphosol Artifical Saliva Tablets2017-03-31

Adverse events under product code LFD

product code LFD

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 →

Recalls naming K234015

K-number listed on FDA's recall record

Z-2012-2025 — Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)Class II·Ongoing·RECORDATI RARE DISEASES INC.·20250611

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K234015.

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