Cleared Traditional

END-IRRIGATING ENDOILLUMINATOR (K931546) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931546 · Infinitech, Inc. · General & Plastic Surgery device
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Feb 1994
Decision
317d
Days
Class 2
Risk

K931546 is an FDA 510(k) clearance for the END-IRRIGATING ENDOILLUMINATOR. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Infinitech, Inc. (Chesterfield, US). The FDA issued a Cleared decision on February 9, 1994 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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. Elevated predicate reliance profile. 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 Infinitech, Inc. devices

Submission Details

510(k) Number K931546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1993
Decision Date February 09, 1994
Days to Decision 317 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 115d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FST Light, Surgical, Fiberoptic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 General & Plastic Surgery devices follow this clearance model.