Cleared Traditional

K023633 - SOVIS OPTIQUE'S ENDOSCOPIC CABLE

K023633 is an FDA 510(k) clearance for SOVIS OPTIQUE'S ENDOSCOPIC CABLE, manufactured by Sovis Optique. The device is a Class 2 Gastroenterology & Urology device with product code FFS cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K023633 · Sovis Optique · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
63d
Days
Class 2
Risk

K023633 is an FDA 510(k) clearance for the SOVIS OPTIQUE'S ENDOSCOPIC CABLE. Classified as Image, Illumination, Fiberoptic, For Endoscope (product code FFS), Class II - Special Controls.

Submitted by Sovis Optique (Washington, US). The FDA issued a Cleared decision on December 31, 2002 after a review of 63 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 Sovis Optique devices

FDA 510(k) Submission Details - K023633

510(k) Number K023633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2002
Decision Date December 31, 2002
Days to Decision 63 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
68d faster than avg
Panel avg: 131d · This submission: 63d
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 16
Devices cleared under the same product code (FFS) and FDA review panel - the closest regulatory comparables to K023633.
PS SERIES
K061622 · Photonic Optische Gerate Gesmbh & Cokg · Mar 2007
TRU-CABLE
K063309 · Truphatek International, Ltd. · Jan 2007
ACCUTECH ENDOLITE PROBE
K061025 · Accutech Medical Technologies, Inc. · May 2006
MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159
K001698 · Cogent Light Technologies, Inc. · Jul 2000
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
K994084 · Smith & Nephew, Inc. · Jan 2000
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
K991323 · Smith & Nephew, Inc. · Jul 1999