Cleared Traditional

K933596 - GASTRIC, CATHETER, IRRIGATION & ASPIRATION

K933596 is an FDA 510(k) clearance for GASTRIC, manufactured by Polamedco, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code BSS cleared through the Traditional 510(k) pathway after a 567-day FDA review.

K933596 · Polamedco, Inc. · Gastroenterology & Urology device
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Feb 1995
Decision
567d
Days
Class 2
Risk

K933596 is an FDA 510(k) clearance for the GASTRIC, CATHETER, IRRIGATION & ASPIRATION. Classified as Tube, Nasogastric (product code BSS), Class II - Special Controls.

Submitted by Polamedco, Inc. (Inglewood, US). The FDA issued a Cleared decision on February 13, 1995 after a review of 567 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Polamedco, Inc. devices

FDA 510(k) Submission Details - K933596

510(k) Number K933596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1993
Decision Date February 13, 1995
Days to Decision 567 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
436d slower than avg
Panel avg: 131d · This submission: 567d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSS Device Classification - Class 2, Special Controls

Product Code BSS Tube, Nasogastric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - BSS Tube, Nasogastric

All 11
Devices cleared under the same product code (BSS) and FDA review panel - the closest regulatory comparables to K933596.
ENTERAL FEEDING TUBE
K051480 · Biosearch Medical Products, Inc. · Oct 2005
MOSS TUBES, INC. NASAL TUBE - MARK IV
K984629 · Moss Tubes, Inc. · Mar 1999
ASPISAFE GASTRIC TUBE
K961711 · B.Braun Medical, Inc. · Jun 1997
RADIUS ENTERAL FEEDING TUBE
K930510 · Radius Intl., Inc. · Feb 1995
AN-10S ANDERSEN TUBE WITH STYLET
K935688 · H.W. Andersen Products, Inc. · Dec 1994
TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR
K934348 · Tri-Med Specialties, Inc. · Dec 1994