Cleared Traditional

FLEX FINDER GUIDEWIRE (K923755) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923755 · Flex Medics Corporation · Gastroenterology & Urology device
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Sep 1993
Decision
406d
Days
Class 2
Risk

K923755 is an FDA 510(k) clearance for the FLEX FINDER GUIDEWIRE. Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by Flex Medics Corporation (Minnetonka, US). The FDA issued a Cleared decision on September 3, 1993 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Flex Medics Corporation devices

Submission Details

510(k) Number K923755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1992
Decision Date September 03, 1993
Days to Decision 406 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
276d slower than avg
Panel avg: 130d · This submission: 406d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCY Endoscopic Guidewire, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Access To Gi Or Gu Tract For The Purpose Of Passing Or Exchanging Other Accessories.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCY Endoscopic Guidewire, Gastroenterology-urology

All 7
Devices cleared under the same product code (OCY) and FDA review panel - the closest regulatory comparables to K923755.
BARD TIGER GUIDEWIRE MODEL 000540
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AMPLATZ SUPER STIFF GUIDEWIRE
K944959 · Boston Scientific Corp · Nov 1994
MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE
K943737 · Boston Scientific Corp · Aug 1994
MICROVASIVE INSURG GEENEN CBD GUIDE WIRE
K931650 · Boston Scientific Corp · Jun 1993
MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177
K892648 · Boston Scientific Corp · May 1989