Cleared Traditional

K963849 - MANAN D BAG

K963849 is the FDA 510(k) clearance for MANAN D BAG by Manan Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EXF) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K963849 · Manan Medical Products, Inc. · Gastroenterology & Urology device
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Dec 1996
Decision
79d
Days
Class 2
Risk

K963849 is an FDA 510(k) clearance for the MANAN D BAG. Classified as Bag, Bile Collecting (product code EXF), Class II - Special Controls.

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on December 13, 1996 after a review of 79 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 K963849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1996
Decision Date December 13, 1996
Days to Decision 79 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 130d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EXF Bag, Bile Collecting
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 - EXF Bag, Bile Collecting

Devices cleared under the same product code (EXF) and FDA review panel - the closest regulatory comparables to K963849.
MERIT DRAINAGE DEPOT
K003078 · Merit Medical Systems, Inc. · Dec 2000
MANAN D BAG
K980005 · Medical Device Technologies, Inc. · Jan 1998
MANAN D BAG
K961986 · Manan Medical Products, Inc. · Mar 1997
URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET
K903449 · Uresil Corp. · Sep 1990
URESIL TRU-CLOSE DRAINAGE BAG
K901844 · Uresil Corp. · Jun 1990