Cleared Traditional

K972225 - UFR FIBEROPTIC CABLE

K972225 is an FDA 510(k) clearance for UFR FIBEROPTIC CABLE, manufactured by Universal Fiberoptic Repair, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K972225 · Universal Fiberoptic Repair, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
278d
Days
Class 2
Risk

K972225 is an FDA 510(k) clearance for the UFR FIBEROPTIC CABLE. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Universal Fiberoptic Repair, Inc. (Pomfret Center, US). The FDA issued a Cleared decision on March 18, 1998 after a review of 278 days - an extended review cycle.

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. 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 Universal Fiberoptic Repair, Inc. devices

FDA 510(k) Submission Details - K972225

510(k) Number K972225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1997
Decision Date March 18, 1998
Days to Decision 278 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 115d · This submission: 278d
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 21
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K972225.
NUVASIVE MAXCESS LIGHT GUIDE
K042034 · Nuvasive, Inc. · Oct 2004
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
K003577 · STERIS Corporation · Jan 2001
ISOLUX SURGICAL HEADLIGHT
K991572 · Isolux America · Jul 1999
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