Cleared Traditional

K983297 - MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL...

K983297 is an FDA 510(k) clearance for MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL..., manufactured by Medtronic Instent, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code ESW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K983297 · Medtronic Instent, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
88d
Days
Class 2
Risk

K983297 is an FDA 510(k) clearance for the MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Medtronic Instent, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 18, 1998 after a review of 88 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 Medtronic Instent, Inc. devices

FDA 510(k) Submission Details - K983297

510(k) Number K983297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1998
Decision Date December 18, 1998
Days to Decision 88 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
42d faster than avg
Panel avg: 130d · This submission: 88d
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 K983297.
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
K012883 · Boston Scientific Corp · Oct 2001
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
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