Cleared Traditional

K923843 - FOGLESS

K923843 is an FDA 510(k) clearance for FOGLESS, manufactured by Sorex Medical. The device is a Class 2 Gastroenterology & Urology device with product code OCT cleared through the Traditional 510(k) pathway after a 602-day FDA review.

K923843 · Sorex Medical · Gastroenterology & Urology device
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Mar 1994
Decision
602d
Days
Class 2
Risk

K923843 is an FDA 510(k) clearance for the FOGLESS. Classified as Anti Fog Solution And Accessories, Endoscopy (product code OCT), Class II - Special Controls.

Submitted by Sorex Medical (Salt Lake City, US). The FDA issued a Cleared decision on March 25, 1994 after a review of 602 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 Sorex Medical devices

FDA 510(k) Submission Details - K923843

510(k) Number K923843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1992
Decision Date March 25, 1994
Days to Decision 602 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
471d slower than avg
Panel avg: 131d · This submission: 602d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCT Device Classification - Class 2, Special Controls

Product Code OCT Anti Fog Solution And Accessories, Endoscopy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens.
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 - OCT Anti Fog Solution And Accessories, Endoscopy

All 18
Devices cleared under the same product code (OCT) and FDA review panel - the closest regulatory comparables to K923843.
ENDOSCOPIC ANTI FOG DEVICE
K993604 · Mectra Labs, Inc. · Mar 2000
DEROYAL INDUSTRIES, INC. DEFOGGER
K982465 · Deroyal Industries, Inc. · Aug 1998
CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004
K974454 · Tucson Medical Corp. · Dec 1997
U.C.E.Z. LENS CLEANER KIT
K925659 · Anago, Inc. · Sep 1993
DR. FOG
K932449 · O.R. Concepts, Inc. · Aug 1993