Cleared Traditional

K980372 - MANAN VS ACCESS NEEDLE/SET

K980372 is the FDA 510(k) clearance for MANAN VS ACCESS NEEDLE/SET by Medical Device Technologies, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K980372 · Medical Device Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
87d
Days
Class 2
Risk

K980372 is an FDA 510(k) clearance for the MANAN VS ACCESS NEEDLE/SET. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Medical Device Technologies, Inc. (Gainsville, US). The FDA issued a Cleared decision on April 27, 1998 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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 Medical Device Technologies, Inc. devices

Submission Details

510(k) Number K980372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1998
Decision Date April 27, 1998
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 313
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K980372.
FLEXIMA
K982508 · Boston Scientific Corp · Oct 1998
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
K982005 · Boston Scientific Scimed, Inc. · Sep 1998
PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM
K980653 · Cordis Corp. · Jun 1998
MANAN BILIARY DRAINAGE CATHETER
K980191 · Medical Device Technologies, Inc. · Feb 1998
MANAN(TM) INTRODUCER SHEATH/NEEDLE
K974815 · Medical Device Technologies, Inc. · Jan 1998
COURIER ST BALLOON DILATATION CATHETER
K973008 · Boston Scientific Corp · Dec 1997