Cleared Traditional

K902177 - MANAN BONE BIOPSY NEEDLE (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K902177 · Manan Medical Products, Inc. · General & Plastic Surgery device
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Sep 1990
Decision
113d
Days
Class 1
Risk

K902177 is an FDA 510(k) clearance for the MANAN BONE BIOPSY NEEDLE. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on September 5, 1990 after a review of 113 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Manan Medical Products, Inc. devices

Submission Details

510(k) Number K902177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1990
Decision Date September 05, 1990
Days to Decision 113 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 114d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDM Needle, Aspiration And Injection, Reusable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.