Cleared Traditional

K042659 - MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K042659 · Medisiss · Gastroenterology & Urology device
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Feb 2005
Decision
139d
Days
Class 1
Risk

K042659 is an FDA 510(k) clearance for the MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS. Classified as Forceps, Biopsy, Non-electric, Reprocessed (product code NON), Class I - General Controls.

Submitted by Medisiss (Redmond, US). The FDA issued a Cleared decision on February 14, 2005 after a review of 139 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.

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Submission Details

510(k) Number K042659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2004
Decision Date February 14, 2005
Days to Decision 139 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 130d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NON Forceps, Biopsy, Non-electric, Reprocessed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1075
Definition Same As Procode Fcl Except This Product Is For The Reprocessed Device. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.