SAF SINGLE-USE AEROSOL FILTER— 510(k) K811203

Name: FDA 510(k) clearance K811203
Creator: U.S. Food and Drug Administration
Published: 1981-05-21

Substantially Equivalent

Sorensen Research

FDA 510(k) clearance K811203 for SAF SINGLE-USE AEROSOL FILTER, Substantially Equivalent on 1981-05-21. Applicant: Sorensen Research. Device class: 1.

Clearance details

Applicant: Sorensen Research
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1981-05-01
Decision date: 1981-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K833674 — ACCURATE MEASUREMENT DEVICE KG-AMD1984-01-25
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K833094 — TRANSDUCER DOME SD1041983-11-03
K833095 — TRANSDUCER DOME SD1051983-11-03
K833096 — TRANSDUCER DOME DS1061983-11-03

Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.