Cleared Traditional

K926408 - SIL-SLIP FLAT SUCTION DRAIN (FDA 510(k) Clearance)

Feb 1994
Decision
408d
Days
Class 1
Risk

K926408 is an FDA 510(k) clearance for the SIL-SLIP FLAT SUCTION DRAIN. This device is classified as a Catheter, Irrigation (Class I - General Controls, product code GBX).

Submitted by Sil-Med Corp. (Taunton, US). The FDA issued a Cleared decision on February 2, 1994, 408 days after receiving the submission on December 21, 1992.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number K926408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1992
Decision Date February 02, 1994
Days to Decision 408 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GBX — Catheter, Irrigation
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4200

Similar Devices — GBX Catheter, Irrigation

All 76
MOERAE VEIN PREPARATION KIT
K131659 · Moerae Matrix, Inc. · Mar 2014
GRAFTGUARD PRESSURE CONTROLLING SYRINGE
K082725 · Maquet Cardiovascular, LLC · Dec 2008
DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
K052286 · The Catheter Exchange, Inc. · Oct 2005
GRAFTSAVER
K043515 · Vescare, Inc. · Mar 2005
MISONIX IRRIGATION SYSTEM MOEDL BC20P
K013417 · Misonix, Inc. · Jan 2002
DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
K000704 · Dmc Medical, Ltd. · May 2000