Cleared Traditional

K902066 - DISPOSABLE BIOPSY FORCEP FOR FLEXIBLE E...

K902066 is an FDA 510(k) clearance for DISPOSABLE BIOPSY FORCEP FOR FLEXIBLE E..., manufactured by Endo-Scientific, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K902066 · Endo-Scientific, Inc. · Gastroenterology & Urology device
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Sep 1990
Decision
121d
Days
Class 2
Risk

K902066 is an FDA 510(k) clearance for the DISPOSABLE BIOPSY FORCEP FOR FLEXIBLE ENDOSCOPES. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Endo-Scientific, Inc. (Clearwater, US). The FDA issued a Cleared decision on September 6, 1990 after a review of 121 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 Endo-Scientific, Inc. devices

FDA 510(k) Submission Details - K902066

510(k) Number K902066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1990
Decision Date September 06, 1990
Days to Decision 121 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 130d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
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 - KNW Instrument, Biopsy

All 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K902066.
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