TLS TM SURGICAL DRAINAGE SYSTEM— 510(k) K800581

Name: FDA 510(k) clearance K800581
Creator: U.S. Food and Drug Administration
Published: 1980-04-04

Substantially Equivalent

Glasrock Products, Inc.

FDA 510(k) clearance K800581 for TLS TM SURGICAL DRAINAGE SYSTEM, Substantially Equivalent on 1980-04-04. Applicant: Glasrock Products, Inc.. Device class: 1.

Clearance details

Applicant: Glasrock Products, Inc.
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1980-03-14
Decision date: 1980-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.