WOUND-EVAC RS— 510(k) K881012

Name: FDA 510(k) clearance K881012
Creator: U.S. Food and Drug Administration
Published: 1988-03-17

Substantially Equivalent

Heritage Medical Products

FDA 510(k) clearance K881012 for WOUND-EVAC RS, Substantially Equivalent on 1988-03-17. Applicant: Heritage Medical Products. Device class: 1.

Clearance details

Applicant: Heritage Medical Products
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1988-03-10
Decision date: 1988-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucker, GA, 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

More clearances from Heritage Medical Products

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K813341 — WOUND-EVAC1981-12-18

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.