Cleared Traditional

K923474 - LOW PROFILE GASTROMSTOMY DEVICE

K923474 is the FDA 510(k) clearance for LOW PROFILE GASTROMSTOMY DEVICE by Biosearch Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K923474 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
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Jan 1993
Decision
175d
Days
Class 2
Risk

K923474 is an FDA 510(k) clearance for the LOW PROFILE GASTROMSTOMY DEVICE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on January 5, 1993 after a review of 175 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosearch Medical Products, Inc. devices

Submission Details

510(k) Number K923474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 14, 1992
Decision Date January 05, 1993
Days to Decision 175 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
45d slower than avg
Panel avg: 130d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 257
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K923474.
FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT
K924697 · Abbott Laboratories · Aug 1993
BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC
K915841 · C.R. Bard, Inc. · Jun 1993
NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEM
K915837 · C.R. Bard, Inc. · Mar 1993
FLEXIFLO COMPANION ENTERAL PUMP SETS AND CONTAINER
K921697 · Abbott Laboratories · Aug 1992
FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT
K915735 · Abbott Laboratories · Jun 1992
FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT
K915110 · Abbott Laboratories · Apr 1992