SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS— 510(k) K850634

Name: FDA 510(k) clearance K850634
Creator: U.S. Food and Drug Administration
Published: 1985-06-28

Substantially Equivalent

Surgidyne, Inc.

FDA 510(k) clearance K850634 for SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS, Substantially Equivalent on 1985-06-28. Applicant: Surgidyne, Inc.. Device class: 1.

Clearance details

Applicant: Surgidyne, Inc.
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1985-02-19
Decision date: 1985-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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K892334 — LEONARD TUBE1989-05-31
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K864822 — VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS1987-01-15
K860030 — SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID1986-02-12
K852180 — SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.1985-07-01

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.