Cleared Traditional

K993358 - SIGHTSURE OPERATION INDICATOR

K993358 is an FDA 510(k) clearance for SIGHTSURE OPERATION INDICATOR, manufactured by Medevices, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K993358 · Medevices, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
161d
Days
Class 2
Risk

K993358 is an FDA 510(k) clearance for the SIGHTSURE OPERATION INDICATOR, MODEL SS301. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Medevices, Inc. (Grayslake, US). The FDA issued a Cleared decision on March 15, 2000 after a review of 161 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Medevices, Inc. devices

FDA 510(k) Submission Details - K993358

510(k) Number K993358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1999
Decision Date March 15, 2000
Days to Decision 161 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 130d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K993358.
RUSCH CANTOR TUBE
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DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
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14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH
K013162 · Medcomp · Oct 2001
TRIP TONOMETRY CATHETER, 14F
K993296 · Datex-Ohmeda, Inc. · Dec 1999
NUTRISAFE EXTENSION TUBE
K991918 · Vygon Corp. · Oct 1999
BARD BALLOON INFLATION SYSTEM
K991375 · C.R. Bard, Inc. · Sep 1999