Cleared Traditional

MANAN(TM) INTRODUCER SHEATH/NEEDLE (K974815) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K974815 · Medical Device Technologies, Inc. · Gastroenterology & Urology device
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Jan 1998
Decision
17d
Days
Class 2
Risk

K974815 is an FDA 510(k) clearance for the MANAN(TM) INTRODUCER SHEATH/NEEDLE. 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 January 9, 1998 after a review of 17 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 K974815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1997
Decision Date January 09, 1998
Days to Decision 17 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
113d faster than avg
Panel avg: 130d · This submission: 17d
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 188
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K974815.
CORDIS NITINOL STENT AND DELIVERY SYSTEM
K980823 · Cordis Corp. · Dec 1998
FLEXIMA
K982508 · Boston Scientific Corp · Oct 1998
PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM
K980653 · Cordis Corp. · Jun 1998
COURIER ST BALLOON DILATATION CATHETER
K973008 · Boston Scientific Corp · Dec 1997
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM
K973113 · Boston Scientific Corp · Nov 1997
OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB
K972825 · Cordis Corp. · Oct 1997