Cleared Traditional

K910678 - TRO-GARD

K910678 is an FDA 510(k) clearance for TRO-GARD, manufactured by Conmedcorp. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K910678 · Conmedcorp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
82d
Days
Class 1
Risk

K910678 is an FDA 510(k) clearance for the TRO-GARD. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on May 8, 1991 after a review of 82 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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: 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 Conmedcorp devices

FDA 510(k) Submission Details - K910678

510(k) Number K910678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1991
Decision Date May 08, 1991
Days to Decision 82 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 115d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGX Tape And Bandage, Adhesive

All 83
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K910678.
3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX
K912520 · 3M Health Care, Ltd. · Jul 1991
AIRSTRIP FIRST AID & POST-OP DRESSING
K911682 · Smith & Nephew United, Inc. · Jul 1991
QUALTEX ISLAND DRESSING
K910657 · Deroyal Industries, Inc. · Jul 1991
ELASTIC ADHESIVE BANDAGE
K910436 · Byron Medical · Mar 1991
ELASTOPLAST
K904500 · Beiersdorf, Inc. · Nov 1990
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · 3M Company · Aug 1990