Cleared Traditional

I/A PROBE LINES (K834577) - FDA 510(k) Clearance

K834577 · Frigitronics of Connecticut, Inc. · General & Plastic Surgery device
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May 1984
Decision
145d
Days
-
Risk

K834577 is an FDA 510(k) clearance for the I/A PROBE LINES.

Submitted by Frigitronics of Connecticut, Inc. (Walker, US). The FDA issued a Cleared decision on May 22, 1984 after a review of 145 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 Frigitronics of Connecticut, Inc. devices

Submission Details

510(k) Number K834577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1983
Decision Date May 22, 1984
Days to Decision 145 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
30d slower than avg
Panel avg: 115d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -