Cleared Traditional

K834249 - MONOJECT SOFT TISSUE BIOPSY NEEDLE

K834249 is the FDA 510(k) clearance for MONOJECT SOFT TISSUE BIOPSY NEEDLE by Sherwood Medical Co.. It is a Class 2 Gastroenterology & Urology device (product code FCG) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K834249 · Sherwood Medical Co. · Gastroenterology & Urology device
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Mar 1984
Decision
96d
Days
Class 2
Risk

K834249 is an FDA 510(k) clearance for the MONOJECT SOFT TISSUE BIOPSY NEEDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Walker, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 96 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 K834249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1983
Decision Date March 12, 1984
Days to Decision 96 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
34d faster than avg
Panel avg: 130d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCG Biopsy Needle
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.