Cleared Traditional

K911155 - OVAL CUP BIOPSY FORCEP

K911155 is an FDA 510(k) clearance for OVAL CUP BIOPSY FORCEP, manufactured by Endovations. The device is a Class 2 Gastroenterology & Urology device with product code FCF cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K911155 · Endovations · Gastroenterology & Urology device
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Aug 1991
Decision
145d
Days
Class 2
Risk

K911155 is an FDA 510(k) clearance for the OVAL CUP BIOPSY FORCEP. Classified as Instrument, Biopsy, Mechanical, Gastrointestinal (product code FCF), Class II - Special Controls.

Submitted by Endovations (Mechanicsburg, US). The FDA issued a Cleared decision on August 7, 1991 after a review of 145 days - within the typical 510(k) review window.

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. 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 Endovations devices

FDA 510(k) Submission Details - K911155

510(k) Number K911155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1991
Decision Date August 07, 1991
Days to Decision 145 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
14d slower than avg
Panel avg: 131d · This submission: 145d
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 K911155.
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K915142 · Intl. Medical, Inc. · Jan 1992
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K843477 · Zimmar Consulting , Ltd. · Dec 1984