Cleared Traditional

K931546 - END-IRRIGATING ENDOILLUMINATOR

K931546 is an FDA 510(k) clearance for END-IRRIGATING ENDOILLUMINATOR, manufactured by Infinitech, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K931546 · Infinitech, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K931546

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.

FST Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FST Light, Surgical, Fiberoptic

All 22
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K931546.
ISOLUX SURGICAL HEADLIGHT
K991572 · Isolux America · Jul 1999
UFR FIBEROPTIC CABLE
K972225 · Universal Fiberoptic Repair, Inc. · Mar 1998
X6000D SILENT SUN LIGHT SOURCE
K955510 · Products For Medicine · Jan 1996
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
K922544 · Kirschner Medical Corp. · Aug 1992
METAL HALIDE LIGHT SOURCE MODEL LM 250
K915274 · Pentax Precision Instrument Corp. · Jan 1992
CUDA SURGICAL LIGHT
K901491 · Cuda Products Co. · Jun 1990