Cleared Traditional

K911225 - TRAY DOUGH

K911225 is the FDA 510(k) clearance for TRAY DOUGH by The Hygenic Corp.. It is a Class 1 General & Plastic Surgery device (product code KGS) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K911225 · The Hygenic Corp. · General & Plastic Surgery device
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Apr 1991
Decision
27d
Days
Class 1
Risk

K911225 is an FDA 510(k) clearance for the TRAY DOUGH. Classified as Retention Device, Suture (product code KGS), Class I - General Controls.

Submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on April 17, 1991 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4930 - 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 The Hygenic Corp. devices

Submission Details

510(k) Number K911225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1991
Decision Date April 17, 1991
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGS Retention Device, Suture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4930
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 - KGS Retention Device, Suture

All 13
Devices cleared under the same product code (KGS) and FDA review panel - the closest regulatory comparables to K911225.
ACUFEX ROTATOR CUFF FIXATION BUTTON
K941740 · Acufex Microsurgical, Inc. · Jun 1995
MITEK CONE WASHER
K930675 · Mitek Surgical Products, Inc. · Nov 1993
VENTROFIL TENSION RELIEF SUTURE SET
K904435 · Aesculap, Inc. · Aug 1991
SURGICAL RETENTION BAR
K902001 · Acufex Microsurgical, Inc. · May 1990
ACUFEX FIXATION BUTTON
K896310 · Acufex Microsurgical, Inc. · Nov 1989
ACUFEX FIXATION BUTTON
K884565 · Acufex Microsurgical, Inc. · Feb 1989