STERISEAL OPHTHALMIC CANNULA— 510(k) K943932

Name: FDA 510(k) clearance K943932
Creator: U.S. Food and Drug Administration
Published: 1995-01-18

Substantially Equivalent

Pharma-Plast, Ltd.

FDA 510(k) clearance K943932 for STERISEAL OPHTHALMIC CANNULA, Substantially Equivalent on 1995-01-18. Applicant: Pharma-Plast, Ltd.. Device class: 1.

Clearance details

Applicant: Pharma-Plast, Ltd.
Product code: Code HMX
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1994-08-12
Decision date: 1995-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redditch, Worcestershire, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code HMX

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K010305 — WEISS RETINAL CANNULA2001-05-02
K000457 — VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES2000-05-09
K970873 — ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)1997-05-20
K942403 — INFUSION CANNULA1994-08-17
K934844 — INTER TIP T1994-04-19

Adverse events under product code HMX

product code HMX

Other: 1
Total: 1

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.