Cleared Traditional

K984168 - BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE

K984168 is an FDA 510(k) clearance for BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCF cleared through the Traditional 510(k) pathway after a 382-day FDA review.

K984168 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
382d
Days
Class 2
Risk

K984168 is an FDA 510(k) clearance for the BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE. Classified as Instrument, Biopsy, Mechanical, Gastrointestinal (product code FCF), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on December 7, 1999 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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. Elevated predicate reliance profile. 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 United States Endoscopy Group, Inc. devices

FDA 510(k) Submission Details - K984168

510(k) Number K984168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1998
Decision Date December 07, 1999
Days to Decision 382 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
251d slower than avg
Panel avg: 131d · This submission: 382d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCF Device Classification - Class 2, Special Controls

Product Code FCF Instrument, Biopsy, Mechanical, Gastrointestinal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 - FCF Instrument, Biopsy, Mechanical, Gastrointestinal

Devices cleared under the same product code (FCF) and FDA review panel - the closest regulatory comparables to K984168.
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OVAL CUP BIOPSY FORCEP
K911155 · Endovations · Aug 1991
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K843477 · Zimmar Consulting , Ltd. · Dec 1984