VARIODRAIN— 510(k) K810636

Name: FDA 510(k) clearance K810636
Creator: U.S. Food and Drug Administration
Published: 1981-05-01

Substantially Equivalent

Colmed, Ltd.

FDA 510(k) clearance K810636 for VARIODRAIN, Substantially Equivalent on 1981-05-01. Applicant: Colmed, Ltd.. Device class: 1.

Clearance details

Applicant: Colmed, Ltd.
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1981-03-10
Decision date: 1981-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K960099 — PENROSE DRAIN MODELS 6001 - 60071996-03-11
K950754 — MACRO SUCTION TUBE MODEL NO 100611995-04-25

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K801208 — HOLLOW BASKET TITANIUM DENTAL IMPLANT1980-05-28
K801006 — CHARNLEY DESIGN HIP PROSTHESIS1980-05-20
K800762 — PS3 TITANIUM SCREW DENTAL IMPLANT1980-05-14

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.