Cleared Traditional

K962375 - MICROVASIVE BALLOON GASTROSTOMY TUBE KIT

K962375 is the FDA 510(k) clearance for MICROVASIVE BALLOON GASTROSTOMY TUBE KIT by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K962375 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
76d
Days
Class 2
Risk

K962375 is an FDA 510(k) clearance for the MICROVASIVE BALLOON GASTROSTOMY TUBE KIT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on September 4, 1996 after a review of 76 days - a notably fast clearance 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: 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 Boston Scientific Corp devices

Submission Details

510(k) Number K962375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1996
Decision Date September 04, 1996
Days to Decision 76 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 130d · This submission: 76d
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 252
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K962375.
LAPAROSCOPIC GASTROSTOMY KIT
K973891 · Applied Medical Resources · Jan 1998
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
K962554 · Abbott Laboratories · Nov 1997
FLEXIFLO POLYG GASTOSTOMY TUBE
K963113 · Abbott Laboratories · Oct 1996
U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE
K955181 · United States Endoscopy Group, Inc. · Jun 1996
U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT
K955248 · United States Endoscopy Group, Inc. · May 1996
KANGAROO JEJUNAL FEEDING SYSTEM
K960677 · Sherwood Medical Co. · May 1996