Cleared Traditional

K993604 - ENDOSCOPIC ANTI FOG DEVICE

K993604 is the FDA 510(k) clearance for ENDOSCOPIC ANTI FOG DEVICE by Mectra Labs, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCT) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K993604 · Mectra Labs, Inc. · Gastroenterology & Urology device
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Mar 2000
Decision
130d
Days
Class 2
Risk

K993604 is an FDA 510(k) clearance for the ENDOSCOPIC ANTI FOG DEVICE. Classified as Anti Fog Solution And Accessories, Endoscopy (product code OCT), Class II - Special Controls.

Submitted by Mectra Labs, Inc. (Bloomfield, US). The FDA issued a Cleared decision on March 3, 2000 after a review of 130 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mectra Labs, Inc. devices

Submission Details

510(k) Number K993604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1999
Decision Date March 03, 2000
Days to Decision 130 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
At panel average
Panel avg: 130d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (OCT) and FDA review panel - the closest regulatory comparables to K993604.
Konix Anti-Fog Solution
K190864 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler · Aug 2020
AMD Anti-Fog Solution
K181887 · Advanced Medical Design Co., Ltd. · Jan 2019
Medline Anti-Fog Solution
K152948 · Medline Industries, Inc. · Feb 2016
DEROYAL INDUSTRIES, INC. DEFOGGER
K982465 · Deroyal Industries, Inc. · Aug 1998