SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN— 510(k) K926496

Name: FDA 510(k) clearance K926496
Creator: U.S. Food and Drug Administration
Published: 1995-05-24

Substantially Equivalent

Sil-Med Corp.

FDA 510(k) clearance K926496 for SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN, Substantially Equivalent on 1995-05-24. Applicant: Sil-Med Corp.. Device class: 1.

Clearance details

Applicant: Sil-Med Corp.
Product code: Code GBX
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1992-12-29
Decision date: 1995-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taunton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GBX

view all

K131659 — MOERAE VEIN PREPARATION KIT2014-03-03
K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE2008-12-17
K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN2005-10-21
K043515 — GRAFTSAVER2005-03-31
K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P2002-01-10

More clearances from Sil-Med Corp.

view all

K972521 — NAVIGATOR (STYLET) 20061997-10-01
K961392 — ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II1997-07-18
K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN1996-08-08
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

Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.