Cleared Traditional

K984068 - FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROST...

K984068 is an FDA 510(k) clearance for FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROST..., manufactured by Schneider (Europe) GmbH. The device is a Class 2 Gastroenterology & Urology device with product code ESW cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K984068 · Schneider (Europe) GmbH · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jan 1999
Decision
52d
Days
Class 2
Risk

K984068 is an FDA 510(k) clearance for the FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Schneider (Europe) GmbH (Bulach, SE). The FDA issued a Cleared decision on January 7, 1999 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3610 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Schneider (Europe) GmbH devices

FDA 510(k) Submission Details - K984068

510(k) Number K984068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1998
Decision Date January 07, 1999
Days to Decision 52 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 130d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ESW Device Classification - Class 2, Special Controls

Product Code ESW Prosthesis, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3610
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - ESW Prosthesis, Esophageal

All 42
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K984068.
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
K012883 · Boston Scientific Corp · Oct 2001
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K010068 · Rusch Intl. · Feb 2001
BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
K002094 · C.R. Bard, Inc. · Oct 2000
ULTRAFLEX
K955347 · Boston Scientific Corp · Feb 1996
COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT
K945201 · Cook, Inc. · Jan 1995
WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)
K940396 · Boston Scientific Scimed, Inc. · Oct 1994