SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID— 510(k) K860030

Name: FDA 510(k) clearance K860030
Creator: U.S. Food and Drug Administration
Published: 1986-02-12

Substantially Equivalent

Surgidyne, Inc.

FDA 510(k) clearance K860030 for SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID, Substantially Equivalent on 1986-02-12. Applicant: Surgidyne, Inc.. Device class: 2.

Clearance details

Applicant: Surgidyne, Inc.
Product code: Code BTA
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 1986-01-06
Decision date: 1986-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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K852180 — SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.1985-07-01
K850634 — SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS1985-06-28

Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.