Cleared Traditional

K873360 - ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG

K873360 is an FDA 510(k) clearance for ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOM..., manufactured by Endovations. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K873360 · Endovations · Gastroenterology & Urology device
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Mar 1988
Decision
222d
Days
Class 2
Risk

K873360 is an FDA 510(k) clearance for the ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Endovations (Camp Hill, US). The FDA issued a Cleared decision on March 30, 1988 after a review of 222 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.

FDA 510(k) Submission Details - K873360

510(k) Number K873360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1987
Decision Date March 30, 1988
Days to Decision 222 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 131d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 651
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K873360.
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K880201 · Superior Healthcare Group, Inc. · Apr 1988
EFFNER FE-EX* OROGASTRIC
K874755 · Effner and Spreine Co. · Apr 1988
J-CATH(TM)
K875171 · Hdc Corp. · Apr 1988
NH REPLACEMENT GASTROSTOMY KIT
K880232 · Biosearch Medical Products, Inc. · Mar 1988
MIC (SPECIFIC LINE) INSERTION KIT
K875126 · Medical Innovations Corp. · Mar 1988
NUTRITION DELIVERY SETS FOR VM 05 AMBULA. PUMP
K871848 · Panamedix, Inc. · Feb 1988
K873360 · ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG
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