Cleared Traditional

MIDKIFF GEOSTATIC CLAMP (K925035) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K925035 · D.L. Nelson and Assoc., Inc. · General & Plastic Surgery device
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Feb 1993
Decision
136d
Days
Class 1
Risk

K925035 is an FDA 510(k) clearance for the MIDKIFF GEOSTATIC CLAMP. Classified as Operating Room Accessories Table Tray (product code FWZ), Class I - General Controls.

Submitted by D.L. Nelson and Assoc., Inc. (Atlanta, US). The FDA issued a Cleared decision on February 18, 1993 after a review of 136 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - 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 D.L. Nelson and Assoc., Inc. devices

Submission Details

510(k) Number K925035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1992
Decision Date February 18, 1993
Days to Decision 136 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 115d · This submission: 136d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FWZ Operating Room Accessories Table Tray
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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.