Cleared Traditional

K083684 - ENDO VIVE STANDARD REPLACEMENT GASTROST...

K083684 is an FDA 510(k) clearance for ENDO VIVE STANDARD REPLACEMENT GASTROST..., manufactured by Manufacturing & Research, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K083684 · Manufacturing & Research, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
55d
Days
Class 2
Risk

K083684 is an FDA 510(k) clearance for the ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Manufacturing & Research, Inc. (Tucson, US). The FDA issued a Cleared decision on February 5, 2009 after a review of 55 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 Manufacturing & Research, Inc. devices

FDA 510(k) Submission Details - K083684

510(k) Number K083684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2008
Decision Date February 05, 2009
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 130d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KNT Device Classification - Class 2, Special Controls

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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K083684.
INSTAFLO BOWEL CATHETER SYSTEM KIT
K100273 · Hollister, Inc. · Apr 2010
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM
K083770 · Coloplast A/S · Nov 2009
SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H
K091759 · Olympus Medical Systems Corporation · Sep 2009
ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
K083153 · Hollister, Inc. · Feb 2009
2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K081739 · Boston Scientific Corp · Dec 2008
ENTERAL ONLY EXTENSION SET
K082654 · Respironics, Inc. · Nov 2008