Cleared Traditional

K920139 - GLEESON CLOT-BUSTER

K920139 is an FDA 510(k) clearance for GLEESON CLOT-BUSTER, manufactured by Conmedcorp. The device is a Class 2 General & Plastic Surgery device with product code GCI cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K920139 · Conmedcorp · General & Plastic Surgery device
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Apr 1992
Decision
93d
Days
Class 2
Risk

K920139 is an FDA 510(k) clearance for the GLEESON CLOT-BUSTER. Classified as Laryngoscope, Endoscope (product code GCI), Class II - Special Controls.

Submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on April 15, 1992 after a review of 93 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Conmedcorp devices

FDA 510(k) Submission Details - K920139

510(k) Number K920139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1992
Decision Date April 15, 1992
Days to Decision 93 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCI Device Classification - Class 2, Special Controls

Product Code GCI Laryngoscope, 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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCI Laryngoscope, Endoscope

All 7
Devices cleared under the same product code (GCI) and FDA review panel - the closest regulatory comparables to K920139.
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K003222 · Computer Motion, Inc. · Nov 2000
AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH
K922123 · United States Surgical, A Division of Tyco Healthc · Feb 1993
POOLE TIP SUCTION PROBE
K915762 · O.R. Concepts, Inc. · Mar 1992
SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT
K914120 · Conmedcorp · Oct 1991
ENDOSTAPLE
K911829 · Ethicon, Inc. · Aug 1991
ENDOSCOPE AND ACCESSORIES
K905117 · Northgate Technologies, Inc. · Apr 1991