Cleared Traditional

SDI C-FLEX STERILE LIGHT HANDLE (K834239) - FDA 510(k) Clearance

K834239 · Sterile Design, Inc. · General & Plastic Surgery device
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Apr 1984
Decision
141d
Days
-
Risk

K834239 is an FDA 510(k) clearance for the SDI C-FLEX STERILE LIGHT HANDLE.

Submitted by Sterile Design, Inc. (Walker, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 141 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 Sterile Design, Inc. devices

Submission Details

510(k) Number K834239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1983
Decision Date April 25, 1984
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -