Cleared Traditional

MANAN INTRODUCER SHEALTH/NEEDLE (K961216) - FDA 510(k) Clearance

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

K961216 · Manan Medical Products, Inc. · Gastroenterology & Urology device
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May 1996
Decision
56d
Days
Class 2
Risk

K961216 is an FDA 510(k) clearance for the MANAN INTRODUCER SHEALTH/NEEDLE. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on May 23, 1996 after a review of 56 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 Manan Medical Products, Inc. devices

Submission Details

510(k) Number K961216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1996
Decision Date May 23, 1996
Days to Decision 56 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 130d · This submission: 56d
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 K961216.
COURIER BALLOON DILATATION CATHETER
K963691 · Boston Scientific Corp · Dec 1996
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K963397 · Boston Scientific Corp · Nov 1996
OLYMPUS B-5/B-7 SERIESBALLOON CATHETER
K962925 · Olympus America, Inc. · Oct 1996
CORDIS BILIARY STENT
K955728 · Cordis Corp. · May 1996
OLYMPUS NBD TUBES
K944912 · Olympus America, Inc. · Jun 1995
OLYMPUS PBD STENTS
K933200 · Olympus Corp. · Apr 1995