ASTRA-VAC— 510(k) K782115

Name: FDA 510(k) clearance K782115
Creator: U.S. Food and Drug Administration
Published: 1979-02-01

Substantially Equivalent

Ab Astra

FDA 510(k) clearance K782115 for ASTRA-VAC, Substantially Equivalent on 1979-02-01. Applicant: Ab Astra. Device class: 1.

Clearance details

Applicant: Ab Astra
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1978-12-27
Decision date: 1979-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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

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.