MEDIASTINAL SILICONE DRAINS— 510(k) K942709

Name: FDA 510(k) clearance K942709
Creator: U.S. Food and Drug Administration
Published: 1996-01-04

Substantially Equivalent for Some Indications

Sil-Med Corp.

FDA 510(k) clearance K942709 for MEDIASTINAL SILICONE DRAINS, Substantially Equivalent for Some Indications on 1996-01-04. Applicant: Sil-Med Corp.. Device class: 1.

Clearance details

Applicant: Sil-Med Corp.
Product code: Code GBW
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1994-06-08
Decision date: 1996-01-04
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Taunton, MA, US

Download summary PDF View on FDA.gov ↗

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K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN1996-08-08
K960426 — MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER1996-03-21

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K961295 — SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR1996-06-26
K960099 — PENROSE DRAIN MODELS 6001 - 60071996-03-11
K955463 — GRIP-A-BOOTS1996-01-23

Adverse events under product code GBW

product code GBW

Death: 6
Total: 6

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.