PERIMETER CLOSED WOUND RESEVOIR— 510(k) K844921

Name: FDA 510(k) clearance K844921
Creator: U.S. Food and Drug Administration
Published: 1985-03-18

Substantially Equivalent

Perimeter Medical, Inc.

FDA 510(k) clearance K844921 for PERIMETER CLOSED WOUND RESEVOIR, Substantially Equivalent on 1985-03-18. Applicant: Perimeter Medical, Inc.. Device class: 1.

Clearance details

Applicant: Perimeter Medical, Inc.
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1984-12-19
Decision date: 1985-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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K972703 — REDYROB-CLOSED WOUND DRAINAGE SYSTEM1997-10-01
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K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-5001996-12-12
K960099 — PENROSE DRAIN MODELS 6001 - 60071996-03-11
K950754 — MACRO SUCTION TUBE MODEL NO 100611995-04-25

More clearances from Perimeter Medical, Inc.

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K844922 — PERIMETER THORACIC CATHETER1985-03-18
K844923 — PERIMETER SUMP DRAIN1985-03-18
K844924 — PERIMETER YANKAUER SUCTION TIPS & SETS1985-03-18
K844925 — PERIMETER MEDIASTINAL DRAIN1985-03-18

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.