Cleared Traditional

K072521 - COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH

K072521 is an FDA 510(k) clearance for COOK FIBER OPTIC BUNDLE AND FLEXOR DEFL..., manufactured by Cook Urological, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFS cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K072521 · Cook Urological, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
74d
Days
Class 2
Risk

K072521 is an FDA 510(k) clearance for the COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH. Classified as Image, Illumination, Fiberoptic, For Endoscope (product code FFS), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on November 20, 2007 after a review of 74 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Urological, Inc. devices

FDA 510(k) Submission Details - K072521

510(k) Number K072521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2007
Decision Date November 20, 2007
Days to Decision 74 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 131d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFS Device Classification - Class 2, Special Controls

Product Code FFS Image, Illumination, Fiberoptic, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - FFS Image, Illumination, Fiberoptic, For Endoscope

All 11
Devices cleared under the same product code (FFS) and FDA review panel - the closest regulatory comparables to K072521.
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
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K982462 · Microvision, Inc. · Sep 1998
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K980636 · Dutch Ophthalmic USA, Inc. · May 1998
VISTA ILLUMINATION SYSTEM
K970217 · Vista Medical Technologies, Inc. · Apr 1997